Bifurcated multicapsule intraluminal grafting system and method

ABSTRACT

An intraluminal grafting system having a balloon catheter assembly, a capsule catheter assembly and capsule jacket assembly is used for deploying in the vessel of an animal body a bifurcated graft having a plurality of attachment systems. The deployment catheters contain an ipsilateral capsule assembly, a contralateral capsule assembly and a distal capsule assembly, wherein the attachment systems of the bifurcated graft are disposed within the three capsule assemblies. A removable sheath of the capsule jacket assembly covers the bifurcated graft and capsule assemblies to provide a smooth transition along the length of the deployment catheters. The bifurcated graft is comprised of a main tubular member and two tubular legs, having attachment systems with wall engaging members secured to the superior end of the main tubular member and the inferior ends of the tubular legs. An inflatable membrane configured on the balloon catheter is used to firmly implant the attachment systems within the vessel. The bifurcated graft and attachment systems are configured to remain in the vessel after the deployment catheters are withdrawn. The method of use of the present intraluminal grafting system is also disclosed, for example, for deploying a bifurcated graft proximate the abdominal aortic bifurcation.

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of application Ser.No. 08/066,414 filed on May 21, 1993, which is a continuation ofapplication Ser. No. 07/684,018 filed on Apr. 11, 1991, now abandoned.The contents of each of these applications are hereby incorporatedherein by reference.

BACKGROUND OF THE INVENTION

[0002] This invention relates to a system and method for emplacing aprosthesis and, more particularly, to a delivery catheter and method ofuse for placement within a corporeal lumen of a bifurcated graft havingattachment systems.

[0003] It is well established that various fluid conducting body orcorporeal lumens, such as veins and arteries, may deteriorate or suffertrauma so that repair is necessary. For example, various types ofaneurysms or other deteriorative diseases may affect the ability of thelumen to conduct fluids and in turn may be life-threatening. In somecases, the damaged lumen is repairable only with the use of prosthesissuch as an artificial vessel or graft.

[0004] For repair of vital vessels such as the aorta, surgical repair issignificantly life-threatening. Surgical techniques known in the artinvolve major surgery in which a graft resembling the natural vessel isspliced into the diseased or obstructed section of the natural vessel.Known procedures include surgically bypassing the damaged or diseasedportion of the vessel and inserting an artificial or donor graftattached to the native vessel by an anastomosis.

[0005] It is known within the art to provide a prosthesis forintraluminal repair of a vessel, such as an abdominal aorta having ananeurysm. The art has taught to provide a prosthesis positioned in avessel then securing the prosthesis within the vessel with hooks orstaples that are mechanically extended by the user. The early prior artdevices were large in diameter, mechanically complex and in turn weresusceptible to mechanical failure. Prior intraluminal grafting systemshave embodied capsule catheters or balloon catheters, but wererelatively stiff and of a relatively high profile. Similarly, the priorart systems were configured in such a way that the graft was relativelydifficult to deploy in the correct position. In addition, prior systemshaving a capsule catheter assembly were usually configured such that theprosthesis was disposed within a unitary capsule.

[0006] In recent years, several devices have been developed to attemptto treat an aortic aneurysm through intraluminal repair. For example,U.S. Pat. No. 4,140,126 (Feb. 20, 1979), Choudhury, discloses a methodand article for performing an aneurysm repair, wherein a prostheticgraft is utilized to replace the damaged segment of the blood vessel. Aplurality of radially spaced anchoring pins are located adjacent eachend of the graft and provide means for securing the graft to the wall ofthe vessel. An assembly is provided for moving the graft within thevessel and permanently anchoring the graft to the wall of the vessel.

[0007] U.S. Pat. No. 4,562,596 (Jan. 7, 1986), Kornberg, discloses abifurcated aortic graft constructed for intraluminal insertion having aplurality of struts having angled hooks with barbs at their superiorends. An assembly for inserting the graft and implanting the hooks intothe vessel lumen is also disclosed.

[0008] U.S. Pat. No. 4,787,899 (Nov. 29, 1988), Lazarus, discloses anintraluminal grafting system including a hollow graft having anattachment means located at one end of the graft. The system includespositioning means for moving the graft within the vessel, thepositioning means having a capsule positioned at one end for coveringthe graft attachment means. The disclosed positioning means furtherincludes an inflatable member for securing the attachment means withinthe lumen.

[0009] EPO Pub. No. 0 461 791 A1 (Dec. 18, 1991), Barone et al.discloses an aortic graft and apparatus for repairing an aneurysm. Thedisclosed system includes a tube graft secured within the aorta and anattachment means at each end of the graft. Intraluminal delivery isaccomplished using a catheter having a balloon for expanding andsecuring the attachment means. The graft and attachment means arepreferably enclosed by a sheath which covers the entire graft andattachment means.

[0010] U.S. Pat. No. 5,104,399 (Apr. 14, 1992), Lazarus, discloses anintraluminal grafting system including a tubular graft having attachmentmeans positioned at both ends. The system includes a positioning meansfor transporting the graft through a vessel lumen and for deploying thegraft within the lumen. The positioning means includes an inflatablemember, a capsule and means for removing the graft from the capsule. Thecapsule is disclosed as a rigid cylindrical member covering the entiregraft.

[0011] EPO Pub. No. 0 508 473 A2 (Oct. 14, 1992), Piplani et al.,discloses an intraluminal grafting system including a catheter having acapsule formed of a helical wrap of metal ribbon. A bifurcated grafthaving attachment means is removably disposed within the capsule. Meansis provided for moving the graft from the capsule, and an inflatablemember is provided for securing the attachment means within a vessellumen.

[0012] U.S. Pat. No. 5,256,150 (Oct. 26, 1993), Quiachon et al.,discloses a large diameter sheath for use in introducing a catheter inthe body of a patient. The sheath includes an flexible elongate sheathtube and a backflow adapter having a hemostatic valve secured to theproximal extremity of the sheath tube. The sheath may be used forintroducing a large-diameter deployment catheter into a femoral arteryof the patient.

[0013] U.S. Pat. No. 5,275,622 (Jan. 4, 1994), Lazarus et al., disclosesan intraluminal grafting system including a catheter having a capsuleformed of a helical wrap of metal ribbon. A tubular graft havingattachment means at both ends is removably disposed within the capsule.Means is provided for moving the graft from the capsule, and aninflatable member is provided for securing the attachment means within avessel lumen.

[0014] The foregoing patents and publications are incorporated herein byreference.

[0015] To provide consistency with the common usage of terms used in themedical surgical arts in the United States, the terms “proximal, distal,inferior and superior” are used with a certain regularity within thepresent specification. Proximal refers to parts of the system, such ascatheters, capsules and wires, which are closest to the user and closestto the portion of the system outside or exterior of the patient. Distalrefers to the point farthest from the user and typically most interiorto the corporeal lumen. The term superior refers to a location situatedabove and is used herein in description of the graft and attachmentsystem. Inferior refers to the point situated below and again is usedherein with the graft and attachment system. Thus, for applications inthe abdominal aorta which use a femoral approach, the superior end ofthe graft resides within the most distal portion of the deliverycatheter. Likewise, the inferior end of the graft resides within theproximal capsule which is on the most distal portion of the capsulecatheter.

[0016] The term “ipsilateral” typically refers to a vessel or part of adevice which resides on the same side in which a device enters a lumen.For example, the ipsilateral tubular leg of a graft would be the tubularleg which resides in the iliac artery in which the capsule catheterenters the aorta. Similarly, the term “contralateral” refers to a vesselor device residing on the opposite side of which the main device entersthe aorta. For example, the contralateral attachment system resides inthe contralateral iliac artery which is on the opposite side of theaorta from which the capsule catheter enters the aorta.

SUMMARY OF THE INVENTION

[0017] The present invention comprises an intraluminal delivery systemfor securing a prosthesis within or between vessels or corporeal lumensof an animal, such as a human. The preferred embodiment of the placementsystem is configured for introducing a graft into a corporeal lumen andpositioning the graft in the area of the aortic bifurcation. Thedelivery system includes a balloon catheter, a capsule catheter and acapsule jacket.

[0018] In general, it is an object of the present invention to providean intraluminal grafting system and method which overcome thedisadvantages of the prior art systems. The present invention comprisesa system and method for implanting a prosthesis utilizing a catheterassembly having a multiplicity of capsules. The prosthesis comprises awye shaped bifurcated graft having a self-expanding attachment system ateach of its three orifices. Each attachment system is contained withinits own compact capsule during deployment. The graft and capsules aredeployed by a catheter assembly designed for traversing the femoral,iliac and aortic vessels of a human anatomy.

[0019] The present system has several advantages over prior art systems.For example, the over the wire configuration of the balloon catheterenables traversing the aneurysm with a guide wire using a guide wire inthis manner minimizes the risk of dislodging thrombus in the aneurysm,since the delivery system follows the guide wire, thereby preventing thedistal tip from perforating the vessel wall. In addition, using a guidewire allows for traversing more difficult anatomy. Also, the guide wirelumen may function as a through lumen for real time angiograms duringthe emplacement procedure or to insert intravascular probes such asintravascular ultrasound systems.

[0020] As another advantage, the smaller diameter of the capsuleassemblies of the present invention permit use of the invention in alarger patient population because the variances in iliac vesseldiameter. Similarly, the smaller device diameter relative to the iliacdiameter may allow for easier navigation inside the corporeal lumenespecially with more difficult anatomy. Likewise, the two capsulesegments of the present invention permit a wider range of graft lengthsthan available with a single capsule design. The single capsule systemsalso require capsules slightly longer than the graft, which imposescertain manufacturing and deployment problems. Moreover, the shortercapsule segments provide a more flexible device, thereby allowingtraversing more difficult anatomy.

[0021] In the preferred embodiment, the balloon catheter and the capsulecatheter include capsule assemblies for retaining the attachmentsystems, including a distal capsule assembly for retaining the superiorattachment system and a proximal capsule assembly for retaining theipsilateral attachment system. Also included within the delivery systemis a contralateral capsule assembly for retaining the contralateralattachment system. The capsule assemblies are movable relative to eachother to allow the graft to be emplaced at the desired location in thecorporeal lumen.

[0022] Preferably, the delivery system includes a balloon catheterhaving a multilumen hollow tube or shaft having a proximal end providedwith an assembly for accepting a guide wire and with an assembly forinflating a balloon or similar inflatable member. The balloon cathetershaft is of sufficient length that the proximal end remains exterior thecorporeal lumen while the distal end of the balloon catheter shaft maybe positioned proximate the portion of the corporeal lumen to berepaired. The balloon catheter further has an assembly for inflating anddeflating the balloon. In addition, the balloon catheter is coupled to acontrol assembly and a distal capsule for retaining and releasing thesuperior end of the graft. In the preferred embodiment, the controlassembly includes a control wire and handle mechanism which providesmovement of the distal capsule relative to the balloon catheter shaft.

[0023] The delivery system also includes a capsule catheter shaped andsized for positioning within the corporeal lumen. The capsule cathetercomprises a hollow tube or shaft slidably mounted on the ballooncatheter shaft, having a proximal end exterior the corporeal lumen formanipulation by the user. The capsule catheter includes a proximal(ipsilateral) capsule secured to the distal end of the capsule cathetershaft for retaining the ipsilateral attachment system. The deliverysystem is configured to provide relative movement between the proximalcapsule of the capsule catheter and the distal capsule of the ballooncatheter for removing the graft from the capsule assemblies and forsubsequently urging the attachment systems into engagement with the wallof the corporeal lumen.

[0024] The placement assembly further includes a capsule jacket forproviding a smooth transition between the parts of the balloon catheterand capsule catheter. The capsule jacket comprises a singled walledjacket or sheath covering the length of the prosthesis and a doublewalled section over the capsule catheter tubular member. The capsulejacket is configured coaxially with the balloon catheter and capsulecatheter, having a proximal end exterior the corporeal lumen formanipulation by the user. The distal end of the capsule jacket is singlewalled and flares outwardly to a size which is slidably retained overthe distal capsule when the placement assembly in deployed into thecorporeal lumen. The capsule jacket distal tip has a radiopaque markerto facilitate positioning using fluoroscopy or x-ray techniques.

[0025] The present invention includes a bifurcated prosthesis orbifurcated graft for intraluminal placement in a fluid conductingcorporeal lumen. For most applications the prosthesis is a hollowbifurcated graft of preselected cross-section and length. The bifurcatedgraft is deformable to conform substantially to the interior surface ofthe corporeal lumen or other body part to be repaired. Preferably, thebifurcated graft is made of a material suitable for permanent placementin the body such as polytetrafluroethylene or a polyester. The tubularlegs and/or the main tubular member of the graft may be crimped toresist kinking during and after deployment. During emplacement, thesuperior and inferior ends of the bifurcated graft are positioned withinthe corporeal lumen and the graft is configured such that the grafttraverses the diseased or damaged portion of the vessel. To anchor thegraft to the wall of the corporeal lumen, attachment systems are securedto the superior and inferior ends of the graft.

[0026] The attachment systems for the ipsilateral and contralateral legsof the bifurcated graft are somewhat smaller than the attachment systemused for the main tubular member. The attachment systems for the legsare sized for emplacement within the iliac arteries. During deployment,the ipsilateral leg attachment system resides within the proximalcapsule and the contralateral leg attachment system resides within thecontralateral capsule. The smaller profile of the leg attachment systemsallow them to fit within the smaller capsules which are configured tofit together within the capsule jacket. Having the leg attachment systemwithin each capsule allows the attachment systems to be secured to thetubular legs prior to deployment. In addition, the encapsulationprevents entanglement of the attachment systems.

[0027] The preferred attachment system has wall engaging members. Thewall engaging members of the superior attachment system are angledtoward the inferior end of the graft. Similarly, the wall engagingmembers of the inferior attachment system are angled slightly toward thesuperior end of the graft. The wall engaging members of both attachmentsystem have sharp tips for engaging the corporeal lumen wall. Thepreferred attachment system are formed into a V-shaped lattice orframework. The frame of the attachment system allows for elastic radialdeformation resulting in a spring-like effect when a compressedattachment system is allowed to expand as the graft is released from thecapsule assembly. In addition, radiopaque markers are secured to thelongitudinal axis of the graft to facilitate orientation of the graftusing fluoroscopy or x-ray techniques.

[0028] The delivery system further includes a contralateral capsulesystem for retaining the contralateral leg of the bifurcated graft. Thecontralateral capsule system comprises a retaining capsule, guiding tubeand a pull wire. A segment of the contralateral capsule guiding tube isconfigured to reside in the capsule jacket, and the remainder of theguiding tube and pull wire extend out of the distal end of the capsulejacket assembly. In addition, a radiopaque marker coil on the guidingtube coincides with the distal capsule of the balloon catheter assemblyto facilitate orientation, i.e. relative twist, between thecontralateral capsule assembly and the ipsilateral capsule assembly.

[0029] During deployment, the contralateral capsule resides within thecapsule jacket and adjacent to the proximal capsule assembly. Thecontralateral capsule guiding tube is traversed through thecontralateral iliac artery in a conventional manner such that thecontralateral leg of the bifurcated graft can be secured within thecontralateral iliac artery. The contralateral capsule is configured toretain the inferior attachment system secured to the contralateraltubular leg. Similarly, the contralateral guiding tube and capsule areconfigured such that the attachment system will remain within thecapsule until such time when the clinician wishes to remove the capsuleand free the attachment system within the contralateral iliac artery.The contralateral pull wire is disposed within the capsule jacket andalong the distal capsule assembly and extends out the distal end of thecapsule jacket.

[0030] Deployment of the graft comprises a series of steps which beginswith introducing the main guide wire into the ipsilateral side of thecorporeal lumen using well known surgical techniques. The contralateralguide wire and guiding tube are then inserted into the ipsilateralcutdown and are traversed through the contralateral cutdown usingstandard transfemoral techniques. Those techniques include use of asnare or guiding catheter traversed through the contralateral cutdown toassist in transferring the contralateral guide wire from the ipsilateralside of the corporeal lumen to the contralateral side. Next, as a singledeployment catheter assembly, the balloon catheter, capsule catheter andcapsule jacket are manipulated over the guide wire to position thecapsules containing the bifurcated graft and attachment systems to adesired location within the corporeal lumen.

[0031] Once the graft is in the desired location, the capsule jacket iswithdrawn to expose the entire graft and capsules containing theattachment systems. As the capsule jacket is retracted, tension isapplied on the contralateral capsule assembly from the contralateralside of the corporeal lumen, thereby pulling the guiding tube out of thecapsule jacket and into the contralateral lumen. The attachment systemsare then simultaneously positioned at the desired locations. The distalcapsule is then moved relative to the balloon catheter shaft and capsulecatheter to expose the superior attachment system.

[0032] After the superior portion of the graft is removed from thedistal capsule assembly, the inflatable member is moved to within thecircumference of the superior attachment system and inflated to urgewall engaging members into the wall of the corporeal lumen. Thecontralateral capsule assembly is then withdrawn to expose the inferiorattachment system of the contralateral tubular leg. An auxiliary ballooncatheter is then positioned in the contralateral tubular leg to firmlysecure the contralateral attachment system.

[0033] Once the contralateral tubular leg is secured, the proximalcapsule assembly is withdrawn from the ipsilateral tubular leg, exposingthe attachment system secured thereto. The deployment catheter is thenmoved to position the inflatable member proximate the ipsilateralinferior attachment system. The inflatable member is then expanded toseat the wall engaging members of the inferior attachment system. Thedeployment catheter is then removed from the corporeal lumen. Anauxiliary balloon catheter is then positioned in the ipsilateral tubularleg to firmly secure the ipsilateral attachment system. All cathetersand guide wires are then removed and the access to the corporeal lumensclosed.

[0034] Other features and advantages of the present invention willbecome apparent from the following detailed description, taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035]FIG. 1 is a top plan view of an intraluminal grafting apparatusand system incorporating the present invention.

[0036]FIG. 2 is a top plan view of a guide wire to be used with theendovascular grafting system of the present invention.

[0037]FIG. 3 is a top plan view of the balloon catheter and ipsilaterallocking wire of the present invention.

[0038]FIG. 4 is a top plan view of the distal cap, control wire,hypotube and control wire handle assembly of the present invention.

[0039]FIG. 5 is a top plan view of the proximal capsule and capsulecatheter assembly of the present invention.

[0040]FIG. 6 is a top plan view of the capsule jacket assembly of thepresent invention.

[0041]FIG. 7 is a top plan view of a bifurcated graft and contralateralcapsule assembly of the present invention.

[0042]FIG. 8 is a partial cross-sectional view of the distal end of theballoon catheter, capsule catheter and capsule jacket assemblies takenalong the line 8-8 of FIG. 1.

[0043]FIG. 9 is an enlarged perspective view showing an embodiment ofthe distal capsule, distal end of the control wire and distal capinsert.

[0044]FIG. 10 is an enlarged cross-sectional view of the distal capsuleassembly of the balloon catheter.

[0045]FIG. 11 is a cross-sectional view taken along the line 11-11 ofFIG. 10.

[0046]FIG. 12 is a partial cross-sectional view of the control wire andcontrol handle mechanism taken along the line 12-12 of FIG. 1.

[0047] FIG. partial is a cross-sectional view taken along the line 13-13of FIG. 12.

[0048]FIG. 14 is a cross-sectional view taken along the line 14-14 ofFIG. 12.

[0049]FIG. 15 is a cross-sectional view taken along the line 15-15 ofFIG. 12.

[0050]FIG. 16 is a cross-sectional view taken along the line 16-16 ofFIG. 12.

[0051]FIG. 17 is an enlarged perspective view of the bifurcated graftand attachment systems of the present invention.

[0052]FIG. 18 is an top plan view showing a superior attachment systemas sewn into the main tubular member of the graft.

[0053]FIG. 19 is an top plan view showing a inferior attachment systemas sewn into a tubular leg of the graft.

[0054]FIG. 20 is an enlarged side plan view showing a superiorattachment system.

[0055]FIG. 21 is an enlarged side plan view showing an attachment systemhaving a supplemental helix torsion spring at the apices.

[0056]FIG. 22 is a top plan view showing a piece of yarn sewn into themain tubular member of a graft adjacent to the vee of an attachmentsystem.

[0057]FIG. 23 is a side plan view of FIG. 22. showing a piece of yarnsewn into the main tubular member of a graft adjacent to the vee of anattachment system.

[0058]FIG. 24 is a top plan view of a torque catheter disposed over theguiding tube of the contralateral capsule assembly of the presentinvention.

[0059]FIG. 25 is a cross-sectional view taken along the line 25-25 ofFIG. 1.

[0060]FIG. 26 is a cross-sectional view taken along the line 26-26 ofFIG. 1.

[0061]FIG. 27 is a partial cross-sectional view of the contralateraltubular leg and attachment system positioned in the contralateralcapsule assembly.

[0062]FIG. 28 is a cross-sectional view taken along the line 28-28 ofFIG. 8.

[0063]FIG. 29 is a partial cross-sectional view of the intraluminalgrafting system shown positioned within the corporeal lumen.

[0064]FIG. 30 is a partial cross-sectional view of the intraluminalgrafting system, wherein the capsule jacket has been withdrawn from thegraft.

[0065]FIG. 31 is a partial cross-sectional view of the intraluminalgrafting system, wherein the contralateral tubular leg and contralateralcapsule assembly have been pulled into the contralateral iliac artery.

[0066]FIG. 32 is a partial cross-section view of the intraluminalgrafting system, wherein the distal capsule has been removed from thesuperior end of the main tubular member and the inflatable member hasbeen expanded to seat the superior attachment system.

[0067]FIG. 33 is a partial cross-sectional view of the intraluminalgrafting system, wherein the contralateral capsule has been removed fromthe inferior end of the contralateral tubular leg and an auxiliaryballoon catheter has been positioned and inflated to seat the inferiorattachment system.

[0068]FIG. 34 is a partial cross-sectional view of the intraluminalgrafting system, wherein the proximal capsule has been removed from theinferior end of the ipsilateral tubular leg, releasing the ipsilateralinferior attachment system into the ipsilateral iliac artery.

[0069]FIG. 35 is a partial cross-sectional view of the intraluminalgrafting system, wherein the inflatable member of the balloon catheterhas been moved and inflated proximate the inferior attachment system ofthe ipsilateral tubular leg.

[0070]FIG. 36 is a partial cross-sectional view of the intraluminalgrafting system., wherein the balloon catheter, capsule catheter andcapsule jacket have been placed in a position for withdrawal from thecorporeal lumen.

[0071]FIG. 37 is an top plan view of a bifurcated graft of the presentinvention having crimped tubular legs.

[0072]FIG. 38 is a contralateral side view of the bifurcated graft ofFIG. 37.

[0073]FIG. 39 is an ipsilateral side view of the bifurcated graft ofFIG. 37.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] As shown in the drawings and for purposes of illustration, theinvention is embodied in an intraluminal grafting system of the typehaving a balloon catheter, a capsule catheter, and a protective sleeveor capsule jacket. One of the novel features of the present system isthe use of a proximal capsule, a distal capsule and a contralateralcapsule to cover the inferior and superior ends of a bifurcated graft tobe implanted in a corporal lumen having a bifurcation. This featureprovides the capability of deploying the inferior end of the graftbefore the superior end or visa versa. Another novel feature of thepresent invention is the use of a sleeve or capsule jacket to create asmooth transition between the proximal capsule, contralateral capsule,distal capsule and bifurcated graft. The uniqueness of the system isaccentuated by the control wire and associated handle which providerelative movement between the distal capsule and the balloon catheter.Providing a contralateral capsule assembly enables including anattachment system in the contralateral tubular leg while avoidingtangling of the tubular legs during deployment.

[0075] In the present system, the graft is comprised of a bifurcatedtubular prosthesis having superior and inferior extremities. Thesuperior extremity of the graft comprises a main tubular member whichbifurcates into two tubular legs which comprise the inferior extremityof the graft. For clarity, the two tubular legs are referred to hereinas the ipsilateral tubular leg and the contralateral tubular leg. Anattachment system is secured to the superior end of the main tubularmember as well as to the inferior ends of each of the tubular legs. Eachattachment system is provided with lumen piercing members which arecovered during deployment by the proximal, distal and contralateralcapsule assemblies. The balloon catheter, capsule catheter and capsulejacket are configured coaxially so that relative movement between themprovides for deployment of the graft. The inflatable member of theballoon catheter is used to firmly implant the attachment systems, andthereby the graft, in the lumen.

[0076] In more detail, the intraluminal grafting system 50 is shown inFIGS. 1-7. As shown in FIG. 1, the system includes a balloon catheterassembly 51, which is coaxially disposed within capsule catheterassembly 52, which is coaxially disposed within capsule jacket assembly53. The proximal capsule assembly 130, contralateral capsule assembly200 and distal capsule assembly 90 are used to contain the bifurcatedgraft 55. A control wire assembly 54 is coaxially disposed within alumen of the balloon catheter assembly and configured to move the distalcapsule assembly in relation to the other system components. In thepreferred embodiment, the system is used as an over-the-wire device,such that the balloon catheter is further configured with a lumen for aguide wire 56. It is contemplated, however, that the system can also beused with well known fixed wire delivery system configurations.

[0077] As shown in FIGS. 1 and 3, the intraluminal grafting system 50also includes a balloon catheter assembly 51 which consists of aninflatable member or balloon 60 secured to a flexible elongate elementor balloon catheter shaft 61. As shown in FIG. 25, the balloon cathetershaft is preferably configured with three lumens; however, the ballooncatheter may be configured with a single, dual or similar multilumenshaft. A guide wire lumen 63 extends the length of the balloon cathetershaft. Similarly, a balloon inflation lumen 64 extends from the proximalend 70 of the balloon catheter to the inflatable member 60, wherein aninflation port 83, FIG. 8, is provided to allow inflation fluid to enterand exit the inflatable member. The third lumen 65 is provided for acontrol wire 91.

[0078] The flexible elongate element or balloon catheter shaft 61 ispreferably formed of a material suitable for intraluminal use, such asirradiated polyethylene tubing. The three lumen balloon catheter shaftis preferably extruded to an outside diameter of 0.08 inches (2.03 mm).The guide wire lumen 63 has an inner diameter of 0.042 inches (1.07 mm).The inflation lumen 64 and the control wire lumen 65 have identicalinner diameters of 0.022 inches (0.56 mm). However, the lumen insidediameter may range from 0.015 to 0.06 inches (0.381-1.52 mm) and theoutside diameter may range from 0.035 to 0.1 inches (0.889-2.54 mm) fora multilumen balloon catheter shaft. The balloon catheter may vary inlength to suit the application, for example, from fifty to onehundred-fifty centimeters.

[0079] Referring to FIG. 1, the proximal extremity 70 of the ballooncatheter shaft 61 is secured to a splitting adapter 71 which splits theguide wire lumen 63 from inflation lumen 64. The side arm 72 of theadapter 71 has a stop cock 73 mounted at its proximal end which ismovable between open and closed positions. The stop cock is providedwith a Luer fitting 74 which is adapted to be secured to a syringe forinjecting inflation fluid. The side arm 75 of the splitting adapter 71is connected to female Luer fitting 77 for distal tip injection and to aTouhy Borst adapter 76 which is configured to removably and slidablyreceive the guide wire 56. A strain relief wire 78 is disposed in thecontrol wire lumen 65 between the splitting adapter and the controlhandle assembly 110.

[0080] The inflatable member or balloon 60 is preferably secured twelvecentimeters from the distal extremity 80 of the balloon catheter shaft61. The balloon is positioned proximal of the distal capsule assembly 90and the superior end of the graft 55. For shorter grafts of four toseven centimeters in length, the inflatable member may be positioneddistal of the distal capsule assembly. The balloon is formed of suitablematerial such as polyethylene. The polyethylene utilized for the balloonis irradiated to achieve an appropriate balloon size. For largerdiameter balloons, higher tensile strength materials likepolyethyleneterephthalate (PET) is desirable because thinner walls,hence a lower profile, can be achieved.

[0081] The balloon can vary in diameter from twelve to forty-fivemillimeters in diameter and can have a wall thickness ranging from 0.001to 0.005 inches (0.0254-0.127 mm). The preferred balloon made inaccordance with the present invention has an outside diameter oftwenty-four millimeters, a diameter equal to the inner diameter of thegraft, and has a wall thickness of approximately 0.003 inches (0.076mm). In addition, the balloon is pleated along its axis for a lowprofile which facilitates its introduction into a corporeal lumen of apatient as hereinafter described. Further, the deflated balloon isheated to provide it with a memory of its low profile configuration.

[0082] The balloon catheter shaft 61 is provided with an inflation lumen64 which is in fluid communication with the inflation port 74. Theinflation lumen is used to inflate and deflate the balloon 60 byintroducing and withdrawing a gas or liquid through the inflation port.The balloon is secured approximately twelve centimeters from the distalextremity 80 of the balloon catheter shaft. The balloon proximal stem 81and balloon distal stem 82 are heat sealed to the balloon catheter shaftto form a fluid tight seal. The length of the proximal stem may varyfrom 0.5 to 1.0 centimeter.

[0083] The balloon catheter shaft 61 has an inflation port 83 locatedapproximately ten millimeters distal the balloon proximal stem 81. Inaddition, a radiopaque marker 84 is embedded in the balloon cathetershaft approximately two millimeters distal the balloon inflation port.Preferably, the radiopaque marker is a platinum or tungsten coil onecentimeter long with an outer diameter of 0.02 inches (0.508 mm) and islocated proximate the center of the balloon 60. Also, a strain relief orsupport wire 97 is disposed in the inflation lumen 64 between the distalend 80 of the balloon catheter shaft and the balloon distal stem 82.

[0084] It should be appreciated that although a separate inflatablemember has been described in the drawing, an integral coaxial inflatablemember may be provided which is formed of the same tubing from which theballoon catheter shaft is made. This can be readily accomplished, as iswell known to those skilled in the art, by using an additional radiationdose for the balloon region of the shaft.

[0085] As shown in FIGS. 1, 3 and 8, the ipsilateral locking wire 85runs parallel to the balloon catheter 61 within the capsule catheterassembly 52. The distal end of the ipsilateral locking wire may beconfigured with a proximal locking ring 86 and a distal locking ring 87secured approximately twelve millimeters apart. The radiopaque lockingrings are disposed within the distal end of the capsule catheterassembly during deployment and secure the ipsilateral attachment systemof the bifurcated graft 55 within the distal end of the capsule catheterassembly. In the preferred embodiment, however, only the distal lockingring is used.

[0086] The proximal end of the ipsilateral locking wire 85 is disposedin the proximal end of the capsule catheter assembly 52. The proximalextremity of the locking wire is configured with a segment of stainlesssteel hypotube approximately sixty millimeters long to form a handle 88.The ipsilateral locking wire handle is used to laterally move theradiopaque proximal and distal locking rings 86 and 87 which engage theipsilateral attachment system of the ipsilateral tubular leg of thebifurcated graft 55. Movement of the handle in relation to the capsulecatheter assembly permits removal of the ipsilateral attachment systemfrom the capsule catheter assembly.

[0087] The balloon 60 can also be observed under x-rays if carbondioxide is used as the inflation medium, because the blood in thepatient's vessel is more opaque than the gas used for inflating theballoon. In addition, increased visibility of the balloon can beobtained by inflating the balloon with a diluted radiopaque contrastsolution. In addition, radiopaque bands of a suitable material such asplatinum or a platinum-tungsten alloy can be placed on the proximal anddistal balloon stems 81 and 82 to aid in ascertaining the position ofthe balloon. Similarly, radiopaque rods may be inserted in the ballooninflation lumen.

[0088] The intraluminal grafting apparatus also includes a control wireassembly 54, which is shown in FIGS. 1 and 4. The distal end of thecontrol wire assembly consists of a distal capsule assembly 90. As shownin more detail in FIGS. 9-11, the distal capsule assembly comprises acontrol wire 91 disposed within a cylindrical distal cap 92 and distalcap insert 96 disposed within the distal cap. The distal cap insert issecured to the distal cap by means of an adhesive, solvent bonding,ultrasonic welding or by heat shrinking. A hollow distal capsule 93 issecured to the distal cap and coaxially surrounds the control wire andballoon catheter shaft 61.

[0089] The control wire 91 is slidably disposed in the control wirelumen 65. A longitudinal slot 94 is cut out of the balloon cathetershaft 61 to expose the control wire lumen and the control wire. Tosecure the control wire within the distal capsule assembly 90, thecontrol wire is threaded through an opening 98 in the distal cap insert96. The control wire is formed in a U-shaped bend over the opening inthe distal cap insert and is configured to slide within the slot and thecontrol wire lumen of the balloon catheter shaft. The distal end 95 ofthe control wire resides in the portion of the control wire lumen beyondthe distal end of the slot.

[0090] The configuration shown in FIGS. 9-11 allows the distal capassembly to move axially along the balloon catheter shaft. The U-shapedbend of the control wire through the distal cap insert, however,prevents the distal cap assembly from rotating in relation to theballoon catheter shaft. As described above, the distal cap insert isfirmly secured within the distal cap 92. To prevent rotation of thedistal cap, a three centimeter length of the control wire extends distalof the distal cap and is slidably disposed in the control wire lumen 65of the balloon catheter shaft 61.

[0091] As shown in FIG. 10, balloon catheter proximal cap 100 is securedto the balloon catheter shaft 61 at a position distal the balloon distalstem 82 and proximal the aperture 94. The proximal cap is secured to theballoon catheter shaft by adhesive and by means of two retaining bumps101 and 102. These retaining bumps secure the proximal cap in place,limiting its movement. Such a configuration provides a rounded,atramatic transition from edge 103 of the distal capsule 93 resting onthe top surface of the proximal cap when the distal capsule is its mostdistal position.

[0092] As the control wire 91 is moved in a longitudinal manner, thedistal end 95 of the control wire, the distal cap insert 96, the distalcap 92 and the distal capsule 93 each move as a single assembly. Theproximal edge 103 of the distal capsule is rolled, curved or crimpedinward, or deburred and smoothened so that the proximal cap will providea smooth transition along the distal capsule assembly 90 when the distalcapsule is advanced. The distal movement of the distal capsule islimited by a third retaining bump 99 positioned approximately 2.5centimeters distal the balloon distal stem 82. The third retaining bumplimits the amount of distal movement of the distal capsule assembly sothat when the assembly is fully advanced the proximal edge of the distalcapsule coincides with the top surface of the proximal cap 100.

[0093] Referring to FIG. 9, the distal cap 92 may be formed frompolycarbonate or other suitable material for insertion through the bodylumen. The distal cap is formed with a bore 104 of approximately thesame diameter as the outer diameter of balloon catheter shaft 61.Similarly, the distal cap insert 96 may be formed of the same materialas the distal cap, wherein the distal cap insert is provided with a bore105 for receiving the balloon catheter shaft. The distal cap is furtherprovided with a recess 106 or other means for receiving the distal endof the distal capsule 93. The distal capsule is preferably formed ofstainless steel, but may be formed of other suitable biocompatiblematerial, such as a nickel titanium.

[0094] Each of the pieces of the distal capsule assembly 90 fit snuglyin a coaxial configuration. The distal cap recess 106 is angled to allowcrimping of the distal capsule 93 to the distal cap 92. In addition, thedistal capsule is configured with a longitudinal semicircular recess 107in which the guiding tube 206 resides during deployment. Similarly, thedistal cap is configured with a cutout slot 108 and the distal capinsert 96 is configured with a longitudinal recess 109 to accept therecess in the distal capsule. The distal cap cutout inhibits therelative rotation between the distal capsule proximal cap 100 andultimately the balloon capsule shaft 61.

[0095] The proximal cap 100 is configured with two concentric alignmentholes 140 in its walls. The alignment holes may range from 1.5 to 2.5millimeters (preferably 2.5) in diameter and are formed 0.5 millimetersfrom the distal edge of the proximal cap. The alignment holes, which arenot radiopaque, are used under fluoroscopy during the deployment of thegraft 55 to indicate the optimal orientation of the main tubular member170 as the superior attachment system 175 is released from the distalcapsule assembly 90.

[0096] The outside diameter of the distal cap 92 and capsule 93 mayrange from 4 to 9 millimeters and is preferably 0.282 inches (7.16 mm)in outer diameter and 0.276 inches (7.01 mm) inner diameter. Similarly,the balloon catheter proximal cap 100 is comprised of stainless steeland has an outside diameter slightly less that of the distal capsule soas to provide a smooth transition. The proximal end of the proximal capis preferably rounded to minimize trauma in the vessel and to facilitateballoon retraction into the bifurcated graft 55 during the emplacementprocess. The distal capsule may range in length from one to fivecentimeters, and preferably is 3.5 centimeters long so as to adequatelyretain the superior extremity of the main tubular member of the graft.

[0097] As shown in FIGS. 12-16, a handle assembly 110 is secured to theproximal end of the control wire 91. The handle assembly comprises aproximal body 111, a distal body 112, a control knob 113 with rotatingshaft 114 and a hypotube 115. The two handle body parts have a centralbore 119 for receiving the balloon catheter shaft 61. A retaining pin129 may be used to secure the two pieces of the handle body together.

[0098] The hypotube 115 is coaxially disposed over the balloon cathetershaft 61 and extends distally from the central bore 119 in the distalhandle body 112. The proximal end of the hypotube is secured to theballoon catheter shaft approximately one centimeter proximal from thedistal end of the distal handle body by means of a polyethylene sealingtube 116 which is heat shrunk over the proximal end of the hypotube. Anadhesive may be used to fix the distal handle body to the hypotube.

[0099] Hypotube 115 consists of a rigid thin wall tube formed of asuitable material such as stainless steel. The hypotube has a length ofabout 55 centimeters and has an outside diameter of 0.095 inches (2.41mm) and an inside diameter of 0.087 inches (2.21 mm). When a crimpedgraft 55 is used, the hypotube may have marker bands (not shown) atpredetermined positions distal of the control handle body 112. A crimpedgraft is loaded into the capsule assemblies in its most stretchedconfiguration. After the capsule jacket assembly 53 is retracted, thenadjustments need to be made to the position of the hypotube relative tothe capsule catheter assembly 52 for the graft to resume its crimpedlength under physiological pressure. The marker bands facilitate thecorrect positioning of the inferior end of the graft.

[0100] Referring to FIG. 12., the control wire 91 resides in a ballooncatheter lumen 65 and extends from the distal capsule assembly 90 to anaperture 117 located in the lumen just proximal of the proximal end ofthe hypotube 115. The control wire preferably consists of an elongatesolid flexible stainless steel wire having a lubricating coating, suchas fluorinated ethylene-propylene (FEP). The coated control wire isabout 0.02 inches (0.508 mm) in diameter, providing sufficient strengthto move the distal capsule assembly without buckling or kinking.

[0101] The proximal end of the control wire 91 is disposed within aretaining rack 120, approximately six centimeters long and having acentral bore to secure the control wire. The retaining racks's proximalend is slidably disposed within a longitudinal guiding slot 121 in theproximal handle 111. Similarly, the retaining rack's distal end isslidably disposed within an longitudinal slot 122 in the distal handlebody 112.

[0102] The retaining rack 120 is configured with teeth 123 along alongitudinal edge which engage a pinion or gear 124. The pinion isattached to a lower end of the rotating shaft 114. The upper end of therotating shaft is secured within the control knob 113 such that rotationof the control knob rotates the gear and in turn moves the retainingrack longitudinally within the guiding slots. Longitudinal movement ofthe retaining rack causes longitudinal movement of the proximal end ofthe control wire 91, causing like longitudinal movement of the distalend 95 of the control wire and of the distal capsule 93. As shown inFIGS. 13 and 15, a locking screw 118 is configured to fix the retainingrack in place. The locking screw ensures that the control wire anddistal capsule will not move even if torque is applied to the controlknob.

[0103] At the base of the control knob 113 is a locking gear 125 whichhas curved teeth. The curved teeth engage a locking pin 126 biased by alocking spring 127 disposed within a recess 128 in the upper surface ofthe proximal body 111 of the control handle 110. The configuration ofthe curved teeth allows the control knob to turn in only one directionwhile the locking pin engages the locking gear. When the locking pin ismoved to compress the locking spring, then the control knob may beturned in either direction. The locking gear is preferably molded aspart of a plastic control knob, but may be a separate mechanism securedto the base of the control knob.

[0104] As shown in FIGS. 1 and 5, the capsule catheter assembly 52consists of a proximal (ipsilateral) capsule catheter assembly 130secured to the distal end of a flexible elongate tubular member 131formed of a suitable plastic material such as polyether block amideavailable under the trademark “PEBAX”, available from Atochem Polymers,Glen Rock, N.J. The capsule catheter elongate tubular member is of asuitable length as, for example, forty to one hundred centimeters andpreferably approximately seventy-five centimeters for the abdominalaortic-iliac arteries and approximately ninety-five centimeters for thethoracic aortic artery. The elongate tubular member has a preferredoutside diameter of 0.187 inches (4.75 mm) and an inside diameter of0.125 inches (3.175 mm). The elongate tubular member can be produced ina certain color such as blue. To render the elongate tubular memberradiopaque under x-rays, its material of construction may contain aradiopaque material, such as twenty percent by weight of bismuthsubcarbonate or barium sulfate. The elongate tubular member may havemarkings or bands distal of the wye adapter 145 at predeterminedpositions to indicate capsule jacket retraction and locking points.

[0105] The proximal catheter assembly 130 includes a proximal(ipsilateral) capsule 132 mounted on the distal extremity of the capsulecatheter elongate tubular member 131. The elongate tubular member alsoserves as a shaft for advancing the proximal capsule, as hereinafterdescribed. Thus, the elongate tubular member should have a diameterwhich is less than that of the proximal capsule, preferably having anoutside diameter ranging from three to seven millimeters.

[0106] The proximal capsule 132 is configured to approximately match thesize of the distal capsule assembly 90. The proximal capsule is somewhatoval in shape, having opposite concave and convex outer surfaces,resembling a crescent moon (FIG. 28). The proximal capsule has apreferred diameter ranging from four to nine millimeters, which may beconfigured to accommodate different size grafts. The proximal capsule ispreferably made of stainless steel or similar impermeable and rigid, orsemi-flexible material.

[0107] Referring to FIG. 8, the proximal (ipsilateral) capsule 132 issecured to the distal extremity of the elongate tubular member 131 bymeans of a capsule adapter assembly 133. The capsule adapter assemblycomprises a housing 134 and an inner sleeve 135, which may beconstructed from polycarbonate. The capsule adapter housing distalextremity 136 is secured in the proximal extremity of the capsule, forexample, by crimping, by using a press fit swaging or an adhesive suchas a cyanoacrylate ester. The capsule adapter housing distal extremitymay be angled to facilitate securing the housing to the proximalcapsule.

[0108] The proximal extremity of the capsule adapter housing 134 issecured to the distal extremity of the elongate tubular member 131 bymeans of an cyanoacrylate ester adhesive, or other suitable means. Tofacilitate a mechanical lock, the elongate tubular member distalextremity is molded to form a flange 137, wherein the capsule adapterhousing is configured so as to close around the flange. The capsuleadapter housing is further provided with a recess for receiving thecapsule adapter inner sleeve 135. The inner sleeve is provided with abore of a suitable diameter so as to allow the balloon catheter shaft 61to reside therein. The inner sleeve may further be provided withradiopaque marker rods or flat ribbons 138 for detection of the capsuleadapter assembly 130 during fluoroscopy. In the preferred embodiment,the flange is bonded to the capsule adapter 134 without using the innersleeve.

[0109] A female Luer adapter with barb (not shown) is secured to theproximal extremity of the elongate tubular member 131 of the capsulecatheter assembly 52 and a wye adapter 145 is secured to the female Lueradapter. The central arm 146 of the wye adapter is connected to a TouhyBorst adapter 147 which tightens around the hypotube 115 disposed in thecentral arm of the wye adapter. The side arm 148 of the wye adapter hasa stop cock 149 mounted therein which is movable between open and closedpositions. The stop cock is provided with a Luer fitting 150 which isconfigured to accept a syringe for injecting a dye or other fluid. Theside arm is also configured with a Touhy Borst adapter 153 whichtightens around the ipsilateral locking wire 85 or preferably with acollet lock mechanism and O-ring (not shown) which tightens around theipsilateral locking wire for hemostasis. The ipsilateral locking wire isdisposed in the capsule catheter assembly 52 through the side arm of thewye adapter and between the balloon catheter shaft 61 and the elongatetubular member 131.

[0110] Air may be purged from the capsule jacket assembly 53 byinjecting fluid through the Luer fitting 150 in the side arm 148. Theinjection fluid and air will exit purge ports 151 and 152, therebyfilling the capsule jacket assembly with injection fluid. The Luerfitting also may be attached to a saline drip line during the operativeprocedure and may be used for contrast hand syringe injections for realtime angiograms. In addition, a length of polyethylene tubing 154 isadhered over and distal the proximal end of the elongate tubular member131 and over the distal end of the wye adapter 145 or female Lueradapter to provide strain relief.

[0111] Referring to FIGS. 1, 6 and 8, the capsule jacket assembly 53 isslidably disposed coaxially over the capsule catheter assembly 52 andthe balloon catheter assembly 51 (FIG. 26). The capsule jacket assemblyis comprised of a main sheath 160, a support sheath 161, a lockingconnector 162 and a sheath adapter 164. The main and support sheaths arecoaxial from their proximal end, to a point approximately twelve totwenty-five centimeters from the distal end 163 of the main sheath,depending on the length of the graft. At the distal extremity of thesupport sheath, the main sheath flares to a larger diameter covering theproximal capsule 132, the contralateral capsule 202, the bifurcatedgraft 55 and the distal capsule 93. The diameter of the main sheath isabout 0.263 inches (6.68 mm) at its proximal end and about 0.3 inches(7.62 mm) at the distal end 163.

[0112] The proximal ends of the sheaths 160 and 161 may be secured tothe sheath adapter 164 of the locking connector by mechanical means andby adhesive. In addition, a length of polyethylene tubing 167 is adheredover the sheath adapter and over the proximal ends of the sheaths tosecure the parts from separating. The distal end of the main sheath ofthe capsule jacket is provided with radiopaque marker 166 about fivemillimeters in longitudinal length.

[0113] When the capsule jacket assembly 53 is in its most distalposition, the distal end 163 of the capsule jacket main sheath 160extends to cover at least a portion of the distal capsule assembly 90.Similarly, the capsule jacket locking connector 162 is therebypositioned just proximal the proximal capsule catheter purge port 151.Prior to insertion into the lumen, the locking ring 165 is turned downto hold the capsule jacket assembly firmly in place, thereby maintaininga smooth transition surface along the length of the intraluminalgrafting system 50. When the locking ring is released, the capsulejacket assembly may be moved to a furthermost proximal position, whereinat least a portion of the proximal capsule catheter assembly is exposed.Thus, the locking connector is positioned just distal the capsulecatheter wye adapter 145. The locking ring may be tightened at anyintermediate position to firmly secure the capsule jacket assembly atthe desired location. In addition, a radiopaque marker 166 is providedat the distal end of the main sheath to facilitate proper linearpositioning of the main sheath.

[0114] As shown in FIGS. 1, 7 and 17, the intraluminal graftingapparatus 50 also includes an expandable, collapsible and flexibleintraluminal vascular bifurcated prosthesis or graft 55 for implantingin a body vessel or corporeal lumen. Referring to FIG. 17, the graftconsists of a deformable main tubular member 170 which bifurcates intoan ipsilateral tubular leg 171 and a contralateral tubular leg 172. Themain tubular member and tubular legs each are formed of a cylindrical orcontinuous wall 173 allowing fluid communication between the superiorand inferior ends of the bifurcated graft.

[0115] The main tubular member 170 may have a length in the range of twoto ten centimeters, where 7.5 centimeters is suitable for most patients.The main tubular member may have a maximum expandable diameter rangingfrom fourteen to forty millimeters and a minimum diameter in a collapsedcondition of 0.175 to 0.3 inches (4.44-7.62 mm). The tubular legs 171and 172 may have a length in the range of three to ten centimeters,where five centimeters is suitable for most patients. The graft wall 173can be woven of any surgical implantable material such aspolytetrafluroethylene or a polyester fiber made from polyethyleneterephthalate (PET), such as “DACRON” (Type 56). One material found tobe satisfactory is “DEBAKEY” soft woven “DACRON” vascular prosthesis.(uncrimped) sold by C.R. Bard of Billerica, Mass. In order to preventunraveling of the woven material at the ends, the ends can be meltedwith heat to provide a small melted bead of material on each end.

[0116] FIGS. 37-39 discloses an alternate embodiment of a bifurcatedgraft 250. Crimps 251 are configured in the ipsilateral andcontralateral tubular legs 252 to resist kinking of the graft whendeployed in a corporeal lumen. The crimps begin just superior to thebifurcation from the main tubular member 253 and are evenly spaced alongthe tubular leg. The crimps discontinue approximately five millimeterssuperior the inferior ends 254 of the tubular legs so as to providesufficient space for the inferior attachment systems (not shown) to besewn into the inferior ends of the tubular legs. The crimps may beannularly or helically spaced along the tubular leg. Similarly, crimpsmay also be provided in the main tubular member of the graft.

[0117] Although a standard size crimp may be used, it is preferred tomake the crimps 251 radially deeper and less numerous than produced fromstandard crimping techniques. Having sparsely crimped tubular legs 252reduces the elongation properties of the bifurcated graft 250. Also, asparsely crimped graft is easier to pack into the capsule jacket than astandard crimped graft. The low bulk and low elongation of the crimpedgraft further allows that the inferior ends of the graft may be packedinto smaller diameter capsules. Similarly, the low crimp elongationfactor allows for a higher degree of placement accuracy in conjunctionwith marker bands on the hypotube of the balloon catheter to adjust forthe physiologic length of the crimped graft.

[0118] Whereas the standard crimp have peak widths of about two timesthe graft wall thickness, the crimps 251 of the bifurcated graft 250 maybe of sufficient width, preferably two millimeters, so as to sew inradiopaque markers 255 on the face of selected crimps. The radiopaquemarkers are preferably “C” shaped and are secured to the edge of thecrimp, allowing for twist detection under fluoroscopy. Similarly, longradiopaque markers 256 and short radiopaque markers 257 are secured tothe edge of the main tubular member 253 to ensure proper alignment ofthe graft 250.

[0119] The distance between the crimps 251, or crimp pitch, ispreferably less than the diameter of the tubular legs 252, so as toresist kinking. The crimp pitch is preferably 3.25 millimeters. Thecrimped graft 250 of the present invention is configured with crimpshaving peaks that are preferably one millimeter deep. So configured, thegraft will maintain its high flexibility even under arterial pressuresof over one hundred mm Hg within the corporeal lumen.

[0120] Referring to FIG. 18, a self-expanding superior attachment system175 is secured adjacent the superior end 171 of the tubular member 170.As shown in FIG. 19, a first self-expanding inferior attachment system176 is secured adjacent the inferior end of the ipsilateral tubular leg171. Similarly, a second self-expanding inferior attachment system 176is secured adjacent the inferior end of the contralateral tubular leg172. Each attachment system serves to yieldably urge the graft 55 from afirst compressed or collapsed position to a second expanded position andprovides a fluid tight seal between the graft and corporeal lumen wall.

[0121] Each attachment system is formed of a plurality of vees 177 withthe outer apices 178 and inner apices 179 of the vees being formed withhelical torsion springs 180. The attachment system may be comprised ofapices numbering from four to twenty-four. The springs yieldably urgethe legs of each of the vees outwardly at a direction approximately atright angles to the plane in which each of the vees lie. The superiorattachment system 175 has both long legs 181 and short legs 182 whichstagger the apices along the superior end of the graft 55. The legs 183of the inferior attachment system 176, however, are of equal length.

[0122] As shown in more detail in FIG. 20, the superior attachmentsystem 175 is comprised of a single piece of wire which is formed toprovide the vees 177 and also to define the helical torsion springs 180between the legs 181 and 182. The two ends of the single piece of wirecan be welded together in one of the legs to provide a continuousspring-like attachment system. In the construction shown in FIGS. 17 and18, it can be seen that the attachment systems have twelve apices lyingin three longitudinally spaced-apart parallel planes which are spacedwith respect to the longitudinal axis of the main tubular member 170.The outer apices 178 residing external of the graft are staggered;whereas, the inner apices 179 residing within the graft lie in the sameplane. Similarly, the apices will lie in four planes if the inner apicesare also staggered.

[0123] The superior and inferior attachment systems 175 and 176 aresecured to the wall 173 of the graft 55 by suitable means such as apolyester-suture material. As shown in FIGS. 18 and 19, sutures or knots190 are used for sewing the inner apices 179 onto the wall of the maintubular member 170 and each tubular leg 171 and 172. Additional sutures191 are preferably formed on each of the superior legs 181 and 182 tofirmly secure each leg to the graft. The legs may be secured so that theapices lying in each plane are staggered to provide for the minimumprofile when the attachment system is placed in its collapsed condition.

[0124] As shown in FIG. 20, wall engaging members 193 are preferablysecured to the legs 181 and 182 of the attachment systems 175 and 176 inthe vicinity of the outer apices 178 by suitable means such as a weld194. The wall engaging members have a diameter ranging from 0.007 to0.018 inches (0.254-0.457 mm) and a length from 0.5 to 5.0 millimeters.The wall engaging members are preferably sharpened to provide conicaltips 195, and should have a length which is sufficient for the tip topenetrate into and perhaps through the corporeal lumen wall. The wallengaging members of the inferior attachment system 176 are configured ina similar manner.

[0125] The superior attachment system 175, inferior attachment system176 and the wall engaging members 193 secured thereto are formed of acorrosion resistant material which has good spring and fatiguecharacteristics. One such material found to be particularly satisfactoryis “ELGILOY” which is a cobalt-chromium-nickel alloy manufactured andsold by Elgiloy of Elgin, Ill. The wire can have a diameter ranging from0.008 to 0.016 inches (0.203-0.406 mm), with a smaller diameter wirebeing utilized for the smaller diameter grafts. For example, 0.012 to0.016 inch (0.305-0.406 mm) diameter wire for the frame and wallengaging members may be used in the larger grafts of eighteen totwenty-eight millimeters diameter, and 0.008 to 0.012 inch (0.203-0.305mm) diameter wire may be used in the smaller grafts being eight tosixteen millimeters in diameter.

[0126] It has been found that the spring force created by the helicaltorsion springs 180 at the apices 178 and 179 is largely determined bythe diameter of the wire. The greater the diameter of the wire, thegreater the spring force applied to the legs 181 and 182 of the vees.Also, the longer the distances are between the apices, the smaller thespring force that is applied to the legs. It therefore has beendesirable to provide a spacing of approximately fifteen millimetersbetween the outer extremities of the legs 181 of the superior attachmentsystem 175. Similarly, a spacing of approximately ten millimetersbetween the outer extremities of the legs 183 of the inferior attachmentsystem 176 is preferable, although smaller or larger distances may beutilized.

[0127]FIG. 21 shows a low stress configuration of an superior attachmentsystem 175 or inferior attachment system 176. An additional helicaltorsion apex 185 is added along the legs 181, 182 or 183 of theattachment system. The additional apices are located adjacent the apicesat the vees 177 formed by the legs. Such a configuration improves thefatigue characteristics of the attachment system. In addition, the weld194 for the wall engaging members 193 may be moved down the attachmentsystem leg 181 or 182 to improve fatigue life. Alternatively, anon-round or non-circular wire, for example, a rectangular, conical orrounded ribbon wire, may be used to reduce the amount of stress in theattachment system and still maintain the spring force of the attachmentsystem.

[0128] To facilitate securing the graft 55 in the corporeal lumen, theconical tips 195 of the wall engaging members 193 on the superiorattachment system 175 may be angled with respect to longitudinal axis ofthe main tubular member 170. The wall engaging members face outwardlyfrom the main tubular member to facilitate holding the graft in place.Preferably, the conical tips of the wall engaging members on thesuperior attachment system are inclined from the longitudinal axis andtoward the inferior end of the graft by 550 to 900 and preferably about850. Likewise, the conical tips 196 of the wall engaging members on theinferior attachment system 176 may be inclined towards the superior endof the graft by 30° to 90° and preferably 85°. By angling the conicaltips of the wall engaging members so that they resist the force of theblood flow, the implanted wall engaging members oppose migration of thegraft.

[0129] The helical torsion springs 180 placed at the apices 178 and 179serve to facilitate compression of the graft 55 to place the superiorand inferior attachment system 175 and 176 within the capsule assemblies90, 130 and 200, as hereinafter described. The compression of the graftis accomplished by deformation of the helical torsion springs to justoutside their elastic limit, thereby having a small component within theplastic range. Placing the apices in different planes and staggering oroffsetting the wall engaging members 193 significantly reduces theminimum compressed size of the graft. Having the conical tips 195 and196 in different planes also helps to prevent the wall engaging membersfrom becoming entangled with each other. The natural spring forces ofthe helical torsion springs serves to expand the graft to its expandedposition as soon as the attachment system is free of the capsules.

[0130] The graft 55 preferably contains a radiopaque marker system forlocating the graft and for detecting any twisting of the graft duringdeployment. As shown in FIG. 17, the radiopaque marker system iscomprised of two sets of relatively long radiopaque markers 197 and twosets of relatively short radiopaque markers 198. The radiopaque markersare made of a suitable material such as a platinum tungsten alloy wireof a suitable diameter such as 0.004 inches (0.102 mm) which is woundinto a spring coil having a diameter of 0.4 inches (1.0 mm). Theradiopaque markers are secured to the wall 173 by sutures, using thesame material used to secure the attachment system to the graft.

[0131] As shown in FIG. 17, the long radiopaque markers 197 are locatedon the wall 173 of the graft 55 in a line parallel to the longitudinalaxis of the main tubular member 170 and extend along the outside of thetubular legs 171 and 172. The first marker is positioned 0.5 centimetersfrom the superior attachment system 175. Additional markers arepositioned intermittently thereafter for the length of the graft. Thelast marker in each set is 0.6 centimeters away from the inferiorattachment system 176. Each long marker has a preferred length of threemillimeters. Thus, the total number of markers in each set depends uponthe length of the graft.

[0132] Each of the second set of radiopaque markers 198 preferably has asmaller length, for example two millimeters, and are positioned alongthe longitudinal axis of the inside of the tubular legs at a position1800 from the first set of markers 197. By placing markers of differentlengths along the axis of the graft 55, it is possible to ascertain theposition of the graft and to determine whether the ipsilateral andcontralateral tubular legs have twisted between their superior andinferior ends. Under fluoroscopy, the two sets markers will be exhibitedas two relatively straight lines for an untwisted graft, wherein atwisted graft will be revealed by a non-linear pattern of markers. Byplacing the markers at equal increments apart, it is possible to usefluoroscopy to ascertain longitudinal compression or tension on thegraft.

[0133] As shown in FIGS. 37-39, the preferred radiopaque marking systemfor a bifurcated graft 250 having crimped tubular legs 252 includes onemillimeter wide by five millimeter long marker coils 255 sewn to thetubular legs. The tubular leg marker coils are sewn horizontally everyone centimeter on the same longitudinal axis as the long and shortradiopaque markers 256 and 257 sewn on the main tubular member. Theradiopaque marker configuration for the main tubular member remains thesame as described above (FIG. 17). When detecting twist of the graftunder fluoroscopy, the tubular leg markers appear with varying widths,ranging from one to five millimeters. The tubular leg markers, however,appear uniform in size for a tubular leg that is not twisted.

[0134] The sizing of the graft 55 may be performed on apatient-by-patient basis, or a series of sizes may be manufactured toadapt to most patient needs. For the repair of an aortic aneurysm, thelength of the graft is selected so to span approximately one centimetersuperior and one centimeter inferior of the aneurysm, wherein the wallengaging members 193 of the graft can seat within normal tissue of thevessel on both sides of the aneurysm. Thus, the graft should be abouttwo centimeters longer than the aneurysm being repaired. During thepreimplant fluoroscopy procedure, a conventional pigtail angiographycatheter is used to determine the locations of the renal arteries toensure the renal arteries will not be covered by the implanted graft.Likewise, on the inferior end of the corporeal lumen, determining thelocation of the internal iliac arteries ensures that they will not becovered by the implanted graft. Also, the diameter of the main tubularmember 170 is selected by measuring the corporeal lumen which willreceive the graft by conventional radiographic techniques and thenselecting a graft with a main tubular member having a diameter at leastone millimeter larger than that measured.

[0135]FIGS. 22 and 23 show an alternative embodiment of the intraluminalgraft 55. A segment of polyester yarn 199 or similar material is used toproduce a “fuzzy” thrombogenic surface to reduce blood leakage andimprove blood clotting and coagulation along the superior end of themain tubular member 170. The filaments of the yarn segment are teasedapart to increase the embolization area. The yarn segment is sutured tothe wall 173 of the graft between one or more of the vees 177 of thesuperior attachment system 175.

[0136]FIG. 22 shows the yarn segment 199 positioned on the graft wall173 inside an outer apex 178; however, the yarn segment may also bepositioned within the vee of an inner apex 179. Similarly, yarn segmentsmay be attached to the graft wall adjacent the inferior attachmentsystems 176 on the ipsilateral and contralateral tubular legs 171 and172. Alternatively, the graft may be made of velour or terry tosimilarly occlude blood flow through the ends of the graft adjacent theattachment system. Likewise, other modifications to the graft wall maybe made to accomplish the same result.

[0137]FIGS. 1, 7, 8, 24 and 27 show the contralateral capsule assembly200 comprising a contralateral capsule 202 and a guiding tube assembly205. The purpose of the contralateral capsule is to retain the inferiorattachment system 176 secured to the contralateral tubular leg 172. Theguiding tube assembly is used to pull the contralateral capsule into thecontralateral artery, e.g., iliac, and is configured to deploy theinferior attachment system when the contralateral tubular leg isproperly positioned. The contralateral capsule is also configured toconnect with a torque catheter 215 to aid in proper deployment of thecontralateral tubular leg.

[0138] As shown in FIG. 27, the contralateral capsule 202 is ofsufficient length to contain the contralateral inferior attachmentsystem 176 secured to the contralateral tubular leg 172. Thecontralateral capsule prevents the conical tips 196 of the wall engagingmembers 193 from contacting the wall of the body lumen prior todeployment of the attachment system. The contralateral capsule is madefrom stainless steel or similar biocompatible material. Thecontralateral capsule is typically 1.5 centimeters long with a internaldiameter of 0.3 centimeters. The contralateral capsule is preferablycircular shaped so as to fit within the indentation of the proximalcapsule 132, as shown in FIG. 28, and is open at its distal end toreceive the inferior attachment system. In addition, the contralateralcapsule may be configured with an indentation (not shown) to prevent theinferior attachment system from rotating within the contralateralcapsule.

[0139] A barbed adapter 203 is fitted within the proximal end of thecontralateral capsule 202 to couple to the distal end of the torquecatheter 215. The barbed adapter is formed around a polyethylene guidingtube 206 which comprises the distal length of the guiding tube assembly205. The distal end of the guiding tube is flared and expanded justdistal of the barbed adapter. A retaining bump 204 may be formed on theguiding tube just proximal of the barbed adapter to secure the adapterin place. As shown in FIG. 8, the barbed adapter is further configuredwith a bore in which the guiding tube resides.

[0140] A distal locking ball 208 and a proximal locking ball 209 arefixed at the distal end of a pull wire 207 about 1.2 centimeters apartand reside within the contralateral capsule. Prior to deployment of thecontralateral tubular leg 172 into the contralateral iliac artery, theinferior attachment system 176 resides in the contralateral capsulebetween the distal and proximal locking balls. As shown in FIG. 27, thecontralateral capsule assembly may be configured with only the distallocking ball, when the inferior attachment system does not need to bepushed from the contralateral capsule.

[0141] The guiding tube assembly 205 comprises the pull wire 207disposed within the distal guiding tube 206 and a proximal guiding tube213. Approximately a distance equal to the length of the graft 55 fromthe contralateral capsule 202, or distal end of the guiding tube, a sixcentimeter segment of the guiding tube is configured with a radiopaquematerial, such as a platinum coil 210. As shown in FIGS. 1 and 8, theradiopaque material marks the point where the guiding tube exits thedistal end 163 of the capsule jacket 160. Such a marking allowsfluoroscopic determination of whether the guiding tube has been twistedor wrapped around the capsule jacket or distal capsule assembly 90.

[0142] The guiding tube assembly 205 is further configured with atapered joint 211 approximately fifty centimeters from the contralateralcapsule 202. The tapered joint connects the distal guiding tube 206 witha proximal guiding tube 213. The tapered proximal end of the distalguiding tube nests inside the flared distal end of the proximal guidingtube. Both guiding tubes are preferably made from polyethylene tubing orsimilar material. The proximal end of the proximal guiding tube isconnected to a 0.035 inch (0.9 mm) diameter contralateral “J” guide wire212 made from stainless steel and having a length of about seventycentimeters.

[0143] The pull wire 207 extends from the contralateral capsule 202 to apoint just distal the proximal end of the proximal guiding tube 213. Thepull wire is fixed at its proximal end to the proximal guiding tube toprevent relative movement between the parts of the guiding tube assembly205 such that pulling on the contralateral guide wire 212 or theproximal guiding tube will cause corresponding movement of thecontralateral capsule. If, however, the guiding tube assembly 205 is cutsomewhere between the tapered joint 211 and the contralateral guidewire, then the proximal portion of the proximal guiding tube can beremoved from the pull wire. Once the assembly is cut, the contralateralcapsule can be moved relative to the pull wire by sliding the distalguiding tube 206 proximally over the pull wire. Black or colored markerbands 214 formed from PET shrink tubing are positioned at predeterminedlocations on the proximal guiding tube to indicate the chronologicalorder in which the sections of the guiding tube assembly is removedduring the deployment process.

[0144] A torque catheter assembly 215 for use with the contralateralcapsule assembly 200 is shown in FIG. 24. The torque catheter assemblyconsists of a torque catheter shaft 216 made of a flexible plasticmaterial, such as PEBAX. The shaft is of sufficient length to span thedistance from the contralateral femoral cutdown to the position in thecontralateral iliac artery where the contralateral attachment system 176is to be deployed, for example, forty centimeters. The torque cathetershaft is provided with a through lumen configured to accept and passover the proximal and distal sections 213 and 206 of the guiding tubeassembly 205.

[0145] The distal end 217 of the torque catheter shaft 216 is configuredto connect to the barb adapter 203 on the contralateral capsule 202. Thedistal end of the shaft is further configured with a radiopaque markerband 218 for use in securing the distal end of the torque catheter tothe barb adapter. Alternatively, the distal end of the shaft may beconfigured with a radiopaque adapter configured to mate with the barbadapter. The distal end of the torque catheter shaft is preferablyprovided with one or more purge ports 219.

[0146] The proximal end 221 of the torque catheter assembly 215 isprovided with a stop cock 222 having a female Luer fitting 223 forinjecting a fluid for purging the torque catheter shaft lumen 220.Likewise, a contrast fluid may be injected through the Luer fitting andout the distal end 217 or purge ports 219 of the torque catheter shaft.The proximal end of the torque catheter shaft is further provided withtwo consecutive Touhy Borst adapters 240 and 241 separated by a singlelumen polyethylene tube 242.

[0147] The distal Touhy Borst adapter 240 locks on the distal guidingtube 206 with the barb adapter 203 engaging the distal end 217 of thetorque catheter shaft 216. This engagement allows torque ability of thecontralateral capsule 202. The proximal Touhy Borst adapter 241 engagesthe proximal guiding tube 213 and ultimately the pull wire 207 whichsecures the contralateral attachment system 176 within the contralateralcapsule. The tapered joint 211 between the distal guiding tube and theproximal guiding tube resides between the two Touhy Borst adapters.

[0148] The distal end of the single lumen polyethylene tube 242 isflared and secured to the cap of the distal Touhy Borst adapter 240. Theproximal end of the polyethylene tube is configured with a barbed femaleLuer fitting 243 on which the proximal. Touhy Borst adapter 241 issecured for engaging the proximal guiding tube 213. To expose the pullwire 207, the proximal Touhy Borst is unlocked and removed from thefemale Luer, thereby removing the proximal guiding tube 213 with theproximal Touhy Borst adapter.

[0149]FIG. 8 depicts the distal end of the intraluminal grafting system50 assembled for deployment. The distal cap 92 is in its retracted orproximal position adjacent to proximal cap 100. Similarly, core wire 91is locked via control knob 113 in its retracted or proximal position.During initial deployment, capsule catheter tubular member 131 is in itsmost distal position in relation to balloon catheter assembly 51 and islocked in place by the locking ring on the Touhy Borst adapter 147.

[0150] The graft 55 is disposed within the distal capsule 93, theproximal capsule 132, the contralateral capsule 202 and the capsulejacket main sheath 160. The superior end of the main tubular member 170and superior attachment system 175 are removably retained within thedistal capsule 93. The inferior end of the ipsilateral tubular leg 171and inferior attachment system 176 are removably retained within theproximal capsule 132. Likewise, the inferior end of the contralateraltubular leg 172 and inferior attachment system 176 are removablyretained within the contralateral capsule 202.

[0151] During initial deployment, the distal end of the balloon catheter80 is positioned such that the distal stem 82 of the balloon 60 resideswithin the main tubular member 170 of the graft 55, as shown in FIG. 8.The proximal cap 100 is positioned just proximal the distal cap 92 andis disposed within the distal capsule 93. In addition, proximal lockingring 86 and distal locking ring 87 are disposed on either side of theipsilateral attachment system 176. Similarly, proximal locking ball 209and distal locking ball 208 are disposed on either side of thecontralateral attachment system 176. In the preferred embodiment, distallocking ring 87 and distal locking ball 208 are disposed just distal ofthe respective attachment systems 176. Also, the capsule jacket assembly53 is positioned such that the distal end 163 of the capsule jacket mainsheath 160 overlaps at least a portion of the distal capsule. Duringdeployment, capsule jacket locking connector 162 secures the main sheathin place. Thus, when any movement or force is applied to the handleassembly 110, the entire apparatus 50 moves as a single unit.

[0152] By way of example, the following describes a method of repair ofan aortic aneurysm using the method comprising the present invention forintraluminal placement of a graft in an aorta. First, a patient isprepared in a conventional manner by use of a guide wire 56, a dilatorand sheath (not shown) to open both ipsilateral and contralateralfemoral arteries or vessels of the patient. The contralateral guide wire212 is then used to feed the guiding tube assembly 205 through thecutdown in the ipsilateral femoral artery and ipsilateral iliac artery228 into the aorta. By conventional means, a basket catheter or similardevice is fed through a cutdown in the contralateral femoral artery tothe contralateral iliac artery 229 to snare or capture the proximal endof the guiding tube assembly. The guiding tube 206 is then pulledthrough the contralateral iliac artery and out the cutdown in thecontralateral femoral artery.

[0153] The distal end of the intraluminal grafting apparatus 50 is theninserted into the sheath, which has previously been placed in thefemoral artery. In the preferred embodiment of the present invention,balloon catheter lumen 63 is provided for receiving the guide wire 56that was previously traversed across the aneurysm. However, thefollowing procedure may also be used when the guiding member isconstructed as part of the balloon catheter.

[0154] Next, the balloon catheter assembly 51, the capsule catheterassembly 52, the capsule jacket assembly 53 and the control wireassembly 54 are all configured for deployment as shown in FIGS. 1 and 8.Thus, the assemblies may be advanced by the physician as a single unitover the main guide wire 56. As shown in FIG. 29, the main guide wire isintroduced by the physician into a cutdown in the ipsilateral femoralartery and advanced through the ipsilateral iliac artery 228 to thedesired location in the abdominal aorta 225 and adjacent to the diseasedor damaged portion 226 of the vessel.

[0155] The physician advances the distal end of the intraluminalgrafting assembly 50 through the ipsilateral femoral artery over theguide wire 56 while maintaining slight tension on the guiding tubeassembly 205 from the cutdown in the contralateral femoral artery.Typically, the desired position for implanting the graft 55 will bewithin the abdominal aorta 225 with the superior extremity of the maintubular member 170 at least one centimeter inferior to the lower renalartery. The inferior attachment systems 176 should be positioned 0.5centimeters superior the internal iliac arteries. However, prior toremoving the contralateral tubular leg 172 from the capsule jacketassembly 53, the proximal capsule assembly 130 and contralateral capsuleassembly 200 must be positioned superior the bifurcation of theabdominal aorta to the ipsilateral iliac artery 228 and contralateraliliac artery 229, as shown in FIG. 29. Fluoroscopy is used to inspectthe position of the radiopaque section 210 of the guiding tube assembly205 to ensure that the distal end of the guiding tube 206 is not wrappedor twisted around the distal capsule assembly 90 as the distal capsule93 first enters the aorta.

[0156] When the proximal capsule assembly 130 and the contralateralcapsule assembly 200 are in the desired position, as shown in FIG. 29,the locking ring 165 of the capsule jacket assembly 53 is loosened toallow movement of the capsule jacket main sheath 160. While using onehand to firmly grasp the capsule catheter assembly 52 and hold itstationary, the physician grasps the sheath adapter 164 with the otherhand and gently pulls the sheath adapter proximally towards the capsulecatheter wye adapter 145. Simultaneously, the physician applies slighttension on the guiding tube assembly 205 from the contralateral side asit is removed from the capsule jacket assembly. The capsule jacketassembly is gradually retracted to sufficiently expose the proximalcapsule 132 to free the contralateral capsule 202. The locking ring isthen tightened to hold the capsule jacket assembly in place such thatthe distal end 163 of the capsule jacket rests near the proximal end ofthe proximal capsule, as shown in FIG. 30. The radiopaque marker 166 atthe distal end of the capsule jacket main sheath may be used to positionthe capsule jacket relative to the proximal capsule. In the alternativeembodiment where the crimped graft 250 is used, the position of thedistal capsule 93 relative to the proximal capsule 132 is adjusted byusing the marker bands on the hypotube 115 to adjust the implant lengthto physiologic length.

[0157] At this point in the procedure, the contralateral tubular leg 172of the graft 55 is moved into the contralateral iliac artery 229 bypulling the guiding tube 206 in a proximal direction, as shown in FIG.31. At the same time and with concurrent motion, the superior end of themain tubular member 170, disposed in the distal capsule 93, is movedinto the desired location of the aorta 225 by moving the control handle110, and thereby the intraluminal grafting assembly 50, in a proximaldirection. By this motion, the inferior end of the ipsilateral tubularleg 171, securely retained within the proximal capsule 132, is moved tothe desired location in the ipsilateral iliac artery 228 for deployingthe ipsilateral attachment system 176. Similarly, the inferior end ofthe contralateral tubular leg, securely retained with in thecontralateral capsule 202, is positioned for deployment of thecontralateral attachment system. Thus, each of the attachment systemsshould be in position for deployment.

[0158] The control knob 113 is then rotated to cause relative movementbetween the distal capsule assembly 90 and the balloon catheter assembly51 to release the superior end of the main tubular member 170 andsuperior attachment system 175 from the distal capsule 93. Rotating thecontrol knob causes the retaining rack 120 to move the control wire 91in a distal direction. Since the distal cap 92 and distal capsule 93 aresecured to the control wire 91, they move in corresponding relationshipwith the rotation of the control knob. As the distal capsule is movedfrom engagement with the superior attachment system, the ballooncatheter proximal cap 100 locates at the proximal end of the distalcapsule. As soon as the distal capsule has cleared the superiorattachment system 175, the superior extremity of the main tubular memberexpands outwardly under the force of the self-expanding attachmentsystem which springs into engagement with the vessel wall 202. Thelocking pin 126 holds the control knob, and thus the control wire anddistal capsule, fixed in place.

[0159] Once the superior attachment system 175 is exposed, steps aretaken to firmly seat or urge the wall engaging members 193 in the vesselwall. First, the locking ring on the capsule catheter Touhy Borstadapter 147 is loosened to permit relative movement between the capsulecatheter assembly 52 and the balloon catheter assembly 51. While thephysician uses one hand to hold the capsule catheter assemblystationary, the handle assembly 110 is grasped by the other hand andpushed distally to position the center of the main balloon 60 into thesuperior extremity of the main tubular member 170. The radiopaque marker84 is used to align the main balloon and superior attachment system.

[0160] Thereafter, a conventional hand operated syringe or inflationassembly (not shown) is attached to the balloon catheter inflation port74. As depicted in FIG. 32, the main balloon 60 is then expanded byintroducing a suitable gas such as carbon dioxide or a dilute radiopaqueliquid from the syringe to urge the wall engaging members 193 outwardlyto firmly emplace the superior conical tips 195 into the vessel wall230. The main balloon may be deflated and inflated repeatedly to ensurethe superior attachment system is firmly implanted in the vessel.

[0161] The main balloon 60 normally remains in an inflated positionduring the next steps of the procedure. During the actual retraction ofthe contralateral capsule 202 and proximal capsule 132, the main balloonshould be inflated, further securing the superior attachment system 175.However, the main balloon may be deflated and reinflated during thefollowing steps to allow the tubular legs 171 and 172 to fill with bloodto facilitate detecting any twisting of the bifurcated graft 55.

[0162] As shown in FIG. 33, the next step is to implant or anchor theinferior attachment system 176 of the contralateral tubular leg 172.Initially, the proximal guiding tube 213 is cut between the single anddouble marker bands 214. Next, the portion of the guiding tubecontaining the single marker band is removed. Then, the torque catheterassembly 215 is passed over the remaining guiding tube assembly 205 soas to engage the distal connector 217 of the torque catheter with thebarb adapter 203 of the contralateral capsule assembly 200, as depictedin FIG. 24. The torque catheter is used to straighten any twists in theguiding tube and can be used to adjust the placement of thecontralateral capsule 202. The torque catheter may remain secured to thecontralateral capsule assembly during the following procedure with thetwo Touhy Borst adapters 240 and 241 locked to the distal and proximalguiding tubes 206 and 213.

[0163] Next, the proximal guiding tube 213 is cut proximal of thetapered joint 211 between the double and triple marker bands 214 toallow relative movement between the distal section of the guiding tube206 and the pull wire 207. Then, the portion of the guiding tubecontaining the double marker band is removed. The proximal Touhy Borstadapter 241 of the torque catheter assembly 215, which is locked to theproximal guiding tube, is disengaged from the Luer fitting 243 exposingthe pull wire 207. Thus, the proximal guiding tube having the triplemarker band is also removed. The pull wire and locking ball 208 are thenadvanced into the contralateral tubular leg 172 by moving the pull wiredistally.

[0164] The torque catheter assembly 215 and distal guiding tube 206 arethen moved in a proximal direction to remove the contralateral capsule202 from the inferior attachment system 176 while the pull wire 207 isheld fixed relative to the torque catheter assembly. The distal end ofthe pull wire and locking ball 208 remain in place inside thecontralateral tubular leg 172. Once the inferior extremity of thecontralateral tubular leg is free of the contralateral capsule, theinferior attachment system will spring open and the wall engagingmembers 193 will engage the contralateral iliac artery wall 231.

[0165] Thereafter, the torque catheter 215 and/or guiding tube 206 andcontralateral capsule 202 are removed through the contralateral femoralartery cutdown. The pull wire 207 is moved distally so that the lockingball 208 is disposed near the superior end of the contralateral tubularleg 172. A conventional (contralateral) balloon catheter 235 is thenmoved into the contralateral iliac artery 229 over the pull wire andpositioned within the inferior attachment system 176. A contralateralballoon 236 configured on the contralateral balloon catheter is theninflated to firmly seat the conical tips 196 of the inferior attachmentsystem into the contralateral iliac artery wall 231. The contralateralballoon may be deflated and reinflated throughout the contralateraltubular leg to open the entire length of the tubular leg. Thecontralateral balloon catheter remains in place with the contralateralballoon inflated during the next sequence of steps; however, thecontralateral balloon catheter, pull wire and locking ball may beremoved once the contralateral attachment system is firmly implanted.

[0166] As shown in FIG. 34, the next step is to deploy the inferiorattachment system 176 of the ipsilateral tubular leg 171 into theipsilateral iliac artery 228. First, the ipsilateral lock adapter 153 isloosened to release the ipsilateral locking wire 85. The ipsilaterallocking wire proximal handle 88 is then moved distally to advance thelocking rings 87 into the superior portion of the ipsilateral tubularleg. Next, the locking mechanism 147 of the capsule catheter wye adapteris loosened. With the handle assembly 110 of the balloon catheterassembly 51 held firmly in place, the capsule catheter assembly 52 ismoved proximally until the inferior attachment system and inferior endof the ipsilateral tubular leg are completely clear of the proximalcapsule 132.

[0167] Once the inferior extremity of the ipsilateral tubular leg 171 isfree of the proximal capsule 132, the ipsilateral inferior attachmentsystem 176 will spring open and the wall engaging members 193 willengage the ipsilateral iliac vessel wall 232. Leaving the main balloon60 inflated while the capsule catheter assembly 52 is moved ensures thatthe superior attachment system 175 will remain firmly secured in place.Thereafter, the ipsilateral locking wire 85 is moved proximally to itsoriginal position and is secured by tightening the locking wire adapter153.

[0168] Next, the main balloon 60 is deflated. As shown in FIG. 35, thehandle assembly 110 is moved proximally so that the main balloon isretracted into the ipsilateral tubular leg 171 and placed adjacent theipsilateral inferior attachment system 176. If the main balloon cannotbe positioned adjacent to the ipsilateral attachment system due tolimited available movement of the handle assembly, then the capsulecatheter locking ring 147 is secured to the hypotube 115, therebysecuring the capsule catheter assembly to the balloon catheter assembly51. The entire deployment catheter 50 is then moved proximally toposition the main balloon adjacent the ipsilateral attachment system.

[0169] The main balloon 60 may be inflated and deflated through theentire length of the main tubular member 170 and ipsilateral tubular leg171 to ensure patency of the bifurcated graft 55. Again, the balloonradiopaque marker 84 is used to align the center of the main balloonwith the ipsilateral attachment system 176. The balloon is then inflatedjust enough to expand the ipsilateral attachment system to tack down thewall engaging members 193 into the ipsilateral iliac artery vessel wall232. Thereafter, the main balloon is finally deflated.

[0170] As shown in FIG. 36, the proximal capsule assembly 130 andballoon 60 are moved proximal the graft 55. First the locking ring 147is loosened. Then, while holding the capsule catheter assembly 52 inplace by grasping the wye adapter 145 with one hand, the ballooncatheter assembly 51 is moved proximally by gently pulling the handleassembly 110 with the other hand. Thus, the capsule catheter assemblyand balloon catheter are in the same relative position as they were justprior to deployment (FIG. 8). Also, the proximal end 103 of the distalcapsule 93 has been mated with the proximal cap 100 for smoothtransition.

[0171] Finally, the capsule jacket locking ring 165 is loosened. Whileholding the capsule jacket sheath adapter 164 in place, the ballooncatheter assembly 51 and capsule catheter assembly 52 are movedproximally and in unison by gently pulling the wye 145 of the capsulecatheter assembly. The catheter assemblies are moved until the distalend 163 of the capsule jacket main sheath 160 covers the proximal cap100 or until the proximal capsule adapter housing 134 mates with theflared transition of the capsule jacket, thereby creating a smoothtransition along the entire length of the intraluminal graftingapparatus 50. Thereafter, the balloon catheter assembly, capsulecatheter assembly, capsule jacket assembly 53 and control wire assembly54 are removed from the aorta through the femoral artery. The graft 55and attachment systems 175 and 176 remain secured to the vessel walls230, 231 and 232, thereby sealing the aneurysm 226 from blood flow.

[0172] When the intraluminal grafting apparatus 50 is removed from theipsilateral iliac and femoral arteries, the main guide wire 56 remainsin place in the vessels. A conventional (ipsilateral) auxiliary ballooncatheter (not shown) is traversed over the main guide wire andpositioned at the inferior end of the ipsilateral tubular leg 171 andwithin the ipsilateral attachment system 176. An ipsilateral auxiliaryballoon on the ipsilateral auxiliary balloon catheter is inflated tofirmly implant the conical tips 196 of the wall engaging members 193into the ipsilateral iliac artery wall 232. The ipsilateral auxiliaryballoon may be inflated and deflated along the entire ipsilateraltubular leg to ensure the tubular leg is completely open and to removecreases which may have set while the graft was loaded in the capsulejacket assembly. Thereafter, the ipsilateral auxiliary balloon catheterand main guide wire are removed from the ipsilateral femoral artery andthe cutdowns are closed.

[0173] The entire procedure described herein can be observed underfluoroscopy. The relative positioning of the graft 55 and the balloon 60can be readily ascertained by the radiopaque attachment systems 175 and176, radiopaque locking mechanisms 87 and 208, radiopaque markers 197and 198 provided on the graft, the radiopaque marker 84 on the balloonshaft 61 and the proximal cap 100. If any twisting of the graft hasoccurred between placement of the superior attachment system and theinferior attachment system, then the twisting can be readily ascertainedby observing the series of markers 197 and 198. Adjustments to eliminateany twisting which may have occurred can be made before exposing theattachment systems by rotation of the balloon catheter 51, the capsulecatheter assembly 52 or the contralateral capsule 132 via the torquecatheter 215. Any excessive graft compression can be ascertained byobserving the radiopaque markers under fluoroscopy. Adjustments toeliminate graft compression can be made before exposing the inferiorextremity of the graft by applying tension on the capsule catheterassembly and torque catheter 215.

[0174] If crimping of the tubular legs of the graft is not employed,then additional attachment systems may be placed within the tubular legsto prevent kinking of the graft material in the tubular legs. Theseadditional attachment systems are placed medial the ends of theipsilateral and/or contralateral tubular legs. Such medial attachmentsystems resemble the inferior attachment systems used to secure theipsilateral and contralateral tubular legs, but the medial attachmentsystem are preferably configured without wall engaging members. Themedial attachment systems are deployed using an auxiliary capsulecatheter traversed over the main guide wire 56 and the contralateralpull wire 207 or another guide wire inserted in the contralateraltubular leg 172 after the contralateral attachment system 176 is firmlyseated.

[0175] Post implant fluoroscopy procedures can be utilized to confirmthe proper implantation of the device by the use of a conventionalpigtail catheter or by injecting dye into the guide wire lumen of theballoon catheter shaft. Thereafter the sheath can be removed from thefemoral artery and the femoral artery closed with conventional suturingtechniques. Tissues should begin to grow into the graft within two tofour weeks with tissue completely covering the interior side of thegraft within six months so that no portion of the graft thereafter wouldbe in communication with the blood circulating in the vessel. Thisestablishes a complete repair of the aneurysm which had occurred.

[0176] While several particular forms of the invention have beenillustrated and described, it will be apparent that variousmodifications can be made without departing from the spirit and scope ofthe invention. For example, references to materials of construction andspecific dimensions are also not intended to be limiting in any mannerand other materials and dimensions could be substituted and remainwithin the spirit and scope of the invention. Accordingly, it is notintended that the invention be limited, except as by the appendedclaims.

What is claimed is:
 1. A prosthesis having a bifurcation for repairingan aortic aneurysm close to or involving the aortic bifurcation havingan arterial wall and comprising the aorta and the first and second iliacarteries extending therefrom and in fluid communication therewith in apatient, the prosthesis comprising: a main tubular body; first andsecond tubular legs joined to said main tubular body in a bifurcation,said main tubular body and said first and second tubular legs beingformed of a flexible surgically implantable material, said main tubularbody and said first and second tubular legs having respectively first,second and third openings therein in fluid communication with eachother; first expandable attachment means for anchoring said main tubularbody, said first attachment means being secured to said main tubularbody adjacent the first opening; second expandable attachment means foranchoring said first tubular leg, said second attachment means beingsecured to said first tubular leg adjacent the second opening; and thirdexpandable attachment means for anchoring said second tubular leg, saidthird attachment means being secured to said second tubular leg adjacentthe third opening, wherein said prosthesis is capable of intraluminalimplantation by a catheter into the aortic bifurcation through the firstiliac artery such that said main tubular body can be anchored by saidfirst attachment means in the aorta, said first tubular leg can beanchored by said second attachment means in the first iliac artery, andsaid second tubular leg can be anchored by said third attachment meansin the second iliac artery.
 2. A prosthesis as in claim 1, wherein saidfirst, second and third attachment means are each in the form of aself-expanding attachment system having outwardly disposed wall engagingmembers.
 3. A prosthesis as in claim 1, wherein said main tubular bodyincludes a plurality of radiopaque markers spaced longitudinally alongsaid main tubular body, such that twisting of the main tubular body maybe detected by viewing the radiopaque markers by fluoroscopy.
 4. Aprosthesis as in claim 1, further comprising a plurality oflongitudinally spaced apart radiopaque markers carried by each of saidfirst and second tubular legs, wherein twisting of said tubular legs maybe detected by viewing said radiopaque markers by fluoroscopy.
 5. Anintraluminal graft deployed using a catheter in the vasculature of apatient, the intraluminal graft comprising: support means forreinforcing a vasculature of a patient, said support means having a maintubular member, a first tubular leg and a second tubular leg in fluidcommunication with the vasculature; a plurality of anchoring means forattaching the main tubular member, the first tubular leg and the secondtubular leg to the vasculature; and means for resisting kinking in thefirst tubular leg and in the second tubular leg.
 6. The intraluminalgraft of claim 5, wherein said means for resisting kinking comprises aplurality of crimps configured in the first tubular leg and in thesecond tubular leg.
 7. The intraluminal graft of claim 5, wherein saidmeans for resisting kinking comprises at least one medial attachmentsystem secured within the first tubular leg and at least one medialattachment system secured within the second tubular leg.
 8. Anintraluminal graft for permanent implantation in a patient's vasculaturefor repairing the vasculature proximate to a bifurcation in thevasculature, the intraluminal graft being intraluminally deployed intothe vasculature using a catheter, the intraluminal graft comprising: amain tubular body having a superior end and configured to resideproximate a bifurcation in a vasculature of a patient, the bifurcationforming a first vessel and a second vessel; a first tubular memberhaving an inferior end and joined to and in fluid communication withsaid main tubular body, said first tubular member configured to extendinto the first vessel; a second tubular member having an inferior endand joined to and in fluid communication with said main tubular body,said second tubular member configured to extend distally into the secondvessel; a first attachment system secured to the superior end of saidmain tubular body; a second attachment system secured to the inferiorend of said first tubular member; and a third attachment system securedto the inferior end of said second tubular member.
 9. The intraluminalgraft of claim 8, further comprising a plurality of crimps configured inthe first tubular member and in the second tubular member.
 10. Theintraluminal graft of claim 8, wherein said first attachment system,said second attachment system and said third attachment system eachinclude a plurality of support members and a plurality of wall engagingmembers, each support member having two legs joined to form an apex,each leg being joined to the legs of adjacent support members to form acircular arrangement of support members about a central axis andoperable between a first collapsed position and a second expandedposition.
 11. The intraluminal graft of claim 10, wherein the supportmembers of said attachment systems further include a first helicalspring and a second helical spring.
 12. The intraluminal graft of claim8, wherein the support members of said attachment systems are formedfrom a non-round wire.
 13. The intraluminal graft of claim 8, furthercomprising means for reducing blood leakage near the superior end of themain tubular body.
 14. The intraluminal graft of claim 13, wherein saidmeans for reducing blood leakage near the superior end of the maintubular body is formed from a segment of biocompatible fiber.
 15. Asystem for implanting a prosthesis in a corporeal lumen having a wall,said system comprising: a bifurcated graft having a superior end, anipsilateral inferior end and a contralateral inferior end, saidbifurcated graft having an attachment system located at each of thesuperior and inferior ends; a capsule catheter having an elongatetubular member having proximal and distal ends, said capsule catheterhaving an ipsilateral capsule positioned at the distal end of theelongate tubular member; a balloon catheter disposed within said capsulecatheter, said balloon catheter including a second elongate tubularmember having proximal and distal ends, an inflatable member positionedproximal the distal end of the second elongate tubular member, and adistal capsule positioned proximate the distal end of the secondelongate tubular member; and a contralateral capsule assemblypositionable proximate the ipsilateral capsule of said capsule catheter,said contralateral capsule assembly including a contralateral capsule,wherein the superior end of said bifurcated graft is removably retainedin the distal capsule, the ipsilateral inferior end is removablyretained in the ipsilateral capsule and the contralateral inferior endis removably retained in the contralateral capsule.
 16. The system asrecited in claim 15, further comprising a capsule jacket slidablypositioned coaxially with said capsule catheter and said ballooncatheter, wherein the capsule jacket is of sufficient length to coverthe ipsilateral capsule, the contralateral capsule and at least aportion of the distal capsule.
 17. The system as recited in claim 15,further comprising: a control wire slidably disposed in a lumen of thesecond elongate tubular member, the control wire having a proximal endand a distal end secured to the distal capsule; and control meansconnected to the proximal end of the control wire for moving the distalcapsule relative to the second elongate tubular member.
 18. The systemas recited in claim 17, wherein said balloon catheter further comprisesa proximal cap secured to the second elongate tubular member, whereinthe proximal cap is configured and positioned to be slidably retainedwithin the distal capsule.
 19. The system as recited in claim 15,wherein said contralateral capsule assembly further includes a guidingtube having a distal end secured to the contralateral capsule and a pullwire disposed within a lumen of the guiding tube, wherein the pull wirehas a distal end configured with a locking ball for retaining within thecontralateral capsule the attachment system located at the contralateralinferior end of the bifurcated graft.
 20. The system of claim 15,wherein said balloon catheter further comprises retaining means forengaging the attachment system located at the ipsilateral inferior endof said bifurcated graft, the retaining means being slidably disposed onthe second elongate tubular member proximal the inflatable member. 21.The system of claim 20, wherein said balloon catheter further compriseslocking means fixedly positioned on the second elongate tubular memberproximal the retaining means for preventing longitudinal movement of theretaining means.
 22. A system for implanting a prosthesis proximate anaortic bifurcation having an aneurism, said system comprising: abifurcated graft having a superior end, an ipsilateral inferior end anda contralateral inferior end, said bifurcated graft having an attachmentsystem located at each of the superior and inferior ends; a capsulecatheter having an elongate tubular member having proximal and distalends, said capsule catheter having an ipsilateral capsule positioned atthe distal end of the elongate tubular member; a balloon catheterdisposed within said capsule catheter, said balloon catheter including asecond elongate tubular member having proximal and distal ends, aninflatable member positioned proximal the distal end of the secondelongate tubular member, and a distal capsule positioned proximate thedistal end of the second elongate tubular member; a contralateralcapsule assembly positionable proximate the ipsilateral capsule of saidcapsule catheter, said contralateral capsule assembly including acontralateral capsule; and a capsule jacket slidably positionedcoaxially with said capsule catheter and said balloon catheter andcovering at least a portion of said contralateral capsule assembly,wherein said capsule jacket is of sufficient length to cover both theipsilateral capsule and at least a portion of the distal capsule suchthat the superior end of said bifurcated graft is removably retained inthe distal capsule, the ipsilateral inferior end is removably retainedin the ipsilateral capsule and the contralateral inferior end isremovably retained in the contralateral capsule.
 23. A system forplacing a bifurcated graft in a lumen formed by a wall proximate anaortic bifurcation having an aneurism, said system comprising: abifurcated graft having a superior extremity, an ipsilateral inferiorextremity and a contralateral inferior extremity, said bifurcated graftbeing deformable between a collapsed condition and an expandedcondition; first anchoring means secured to the superior extremity ofsaid bifurcated graft for attaching the superior extremity of saidbifurcated graft to the lumen wall; second anchoring means secured tothe ipsilateral inferior extremity of said bifurcated graft forattaching the ipsilateral inferior extremity of said bifurcated graft tothe lumen wall; third anchoring means secured to the contralateralinferior extremity of said bifurcated graft for attaching thecontralateral inferior extremity of said bifurcated graft to the lumenwall; a distal capsule assembly for covering said first anchoring means;an ipsilateral capsule assembly for covering said second anchoringmeans; a contralateral capsule assembly for covering said thirdanchoring means, wherein at least a portion of said bifurcated graftbetween said first, second and third anchoring means remains uncoveredby the capsules; a removable sleeve of a flexible material, saidremovable sleeve configured to extend over said inferior capsuleassembly, said bifurcated graft and at least a portion of saidcontralateral capsule assembly and said distal capsule assembly, whereina smooth transition is provided between said ipsilateral capsuleassembly, said contralateral capsule assembly and said distal capsuleassembly; a first catheter including a balloon secured to a firstflexible elongate shaft having an inflation lumen in fluid communicationwith the balloon, said first catheter being capable of moving theballoon within said bifurcated graft and into engagement with said firstanchoring means and with said second anchoring means; a control wirehaving a proximal end and a distal end secured to the distal capsuleassembly, the shaft of the first catheter being provided with a controlwire lumen for slidably retaining the control wire, wherein the distalcapsule assembly moves relative to the shaft by movement of the proximalend of the control wire; and a second catheter including a secondflexible elongate shaft having a proximal end positioned distal theproximal end of the first shaft of said first catheter and having adistal end secured to the ipsilateral capsule assembly, such thatmovement of said second catheter may move said ipsilateral capsuleassembly without moving said distal capsule assembly, wherein the firstshaft of said first catheter is coaxially disposed within the secondshaft of said second catheter, said removable sleeve being coaxiallydisposed over both the first shaft the second shaft.
 24. The system asrecited in claim 23, wherein said contralateral capsule assembly furtherincludes a contralateral capsule, a guiding tube having a distal endsecured to the contralateral capsule and a pull wire disposed within alumen of the guiding tube, wherein the pull wire has a distal endconfigured with a locking ball for retaining the third anchoring meanswithin the contralateral capsule.
 25. A method for securing a bifurcatedgraft in a corporeal lumen, the bifurcated graft having a superior end,an ipsilateral inferior end and a contralateral inferior end, thebifurcated graft further having a superior attachment system disposedproximate the superior end, an ipsilateral attachment system disposedproximate the ipsilateral inferior end and a contralateral attachmentsystem disposed proximate the contralateral inferior end, said methodcomprising the steps of: providing a delivery catheter assembly havingdistal capsule means for containing the superior attachment system ofthe bifurcated graft, ipsilateral capsule means for containing theipsilateral attachment system and contralateral capsule means forcontaining the ipsilateral attachment system; positioning the deliverycatheter assembly and the bifurcated graft at a desired location withina corporeal lumen; withdrawing the distal capsule means from thesuperior end of the bifurcated graft to expose the superior attachmentsystem; withdrawing the contralateral capsule means from thecontralateral inferior end of the bifurcated graft to expose thecontralateral attachment system; withdrawing the ipsilateral capsulemeans from the ipsilateral inferior end of the bifurcated graft toexpose the ipsilateral attachment system; and removing the deliverycatheter from the corporeal lumen, wherein the bifurcated graft remainssecured within the corporeal lumen.
 26. The method of claim 25, whereinthe positioning step includes placing the bifurcated graft proximate ananeurism proximate an aortic bifurcation.
 27. A method for emplacementof a bifurcated graft in a corporeal lumen having a wall, the bifurcatedgraft having a plurality of attachment systems and being disposed withina delivery catheter assembly including a balloon catheter having adistal capsule, an inflatable member and a first shaft coupled to thedistal capsule and the inflatable member, the delivery catheter assemblyfurther including a capsule catheter having an ipsilateral capsule andsecond shaft coupled to the ipsilateral capsule, the delivery catheterfurther including a contralateral capsule assembly having acontralateral capsule, said method comprising the steps of: manipulatingthe delivery catheter assembly to advance the bifurcated graft, theballoon catheter, the capsule catheter and the contralateral capsuleinto a corporeal lumen, wherein the bifurcated graft and each attachmentsystem are removably retained in the distal, ipsilateral andcontralateral capsules to prevent the attachment systems from contactingthe corporeal lumen wall while the bifurcated graft is being advancedthrough the corporeal lumen; positioning the bifurcated graft at adesired location in the corporeal lumen; removing the attachment systemsfrom the distal, ipsilateral and contralateral capsules; inflating theinflatable member to engage at least one attachment system of thebifurcated graft so that the attachment system and the bifurcated graftare secured to the corporeal lumen wall; deflating the inflatablemember; and withdrawing the delivery catheter assembly from thebifurcated graft and from the corporeal lumen, wherein the bifurcatedgraft is retained within the corporeal lumen.
 28. The method of claim27, wherein the delivery catheter assembly further includes a capsulejacket coaxially disposed over the capsule catheter, and the ballooncatheter is coaxially disposed within the capsule catheter, such thatthe capsule jacket covers the bifurcated graft, the ipsilateral capsule,the contralateral capsule and at least a portion of the distal capsule,said method further comprising the step of withdrawing the capsulejacket from the bifurcated graft prior to removing the attachmentsystems from the distal, ipsilateral and contralateral capsules.
 29. Amethod for implanting a bifurcated graft in a corporeal lumen having awall afflicted by an aneurysm having a superior end, the bifurcatedgraft including a superior attachment system having wall engagingmembers, an ipsilateral attachment system having wall engaging membersand a contralateral attachment system having wall engaging members, saidmethod comprising the steps of: covering the ipsilateral attachmentsystem of the bifurcated graft with an ipsilateral capsule, theipsilateral capsule being coupled to a first shaft; covering thesuperior attachment system of the bifurcated graft with a distalcapsule, the distal capsule being coupled to a second shaft in fluidcommunication with a main balloon, wherein the second shaft is coaxiallyand slidably disposed within the first shaft; covering the contralateralattachment system of the bifurcated graft with a contralateral capsule,the contralateral capsule being coupled to a pull wire; covering thebifurcated graft, the ipsilateral capsule, the contralateral capsule andat least a portion of the distal capsule and pull wire with a sheathslidably disposed over the first and second shafts; introducing thebifurcated graft, distal capsule, ipsilateral capsule, contralateralcapsule, pull wire, balloon and at least a portion of the first shaft,second shaft and sheath into a corporeal lumen; positioning thebifurcated graft such that the superior attachment system is locatedsuperior to the superior end of the aneurysm; removing the sheath fromthe distal capsule, the contralateral capsule and at least a portion ofthe ipsilateral capsule; removing the distal capsule from the superiorattachment system; positioning the main balloon adjacent the superiorattachment system; inflating the main balloon to urge the wall engagingmembers of the superior attachment system into the wall of the lumen;removing the contralateral capsule from the inferior attachment systemand from the corporeal lumen; inserting an auxiliary balloon into thecorporeal lumen adjacent the contralateral attachment system; inflatingthe auxiliary balloon to urge the wall engaging members of thecontralateral attachment system into the wall of the lumen; removing theipsilateral capsule from the ipsilateral attachment system; deflatingthe auxiliary balloon; removing the auxiliary balloon from the corporeallumen; deflating the main balloon; positioning the main balloon adjacentthe ipsilateral attachment system; inflating the main balloon to urgethe wall engaging members of the ipsilateral attachment system into thewall of the lumen; deflating the main balloon; and removing the mainballoon, distal capsule, ipsilateral capsule, first shaft, second shaftand sheath from the corporeal lumen, wherein the bifurcated graft isretained in the lumen.
 30. The method of claim 29, wherein saidintroducing the bifurcated graft step includes providing an opening inat least one femoral artery and said positioning the bifurcated graftstep includes placing the bifurcated graft proximate an aorticbifurcation.
 31. A method for engrafting a bifurcated prosthesis into acorporeal lumen, the bifurcated prosthesis having a superior end, anipsilateral end and a contralateral end, the bifurcated prosthesisfurther having a superior attachment system at the superior end, anipsilateral attachment system at the ipsilateral end and a contralateralattachment system at the contralateral end, said method comprising thesteps of: (a) providing delivery means for positioning a bifurcatedprosthesis in a corporeal lumen, wherein the delivery means comprisesdistal capsule means for removably retaining a superior attachmentsystem, ipsilateral capsule means for removably retaining an ipsilateralattachment system and contralateral capsule means for removablyretaining a contralateral attachment system; (b) providing capsulejacket means for removably retaining the bifurcated prosthesis, distalcapsule means, ipsilateral capsule means and contralateral capsulemeans; (c) placing the superior attachment system of the bifurcatedprosthesis into the distal capsule means; (d) placing the ipsilateralattachment system of the bifurcated prosthesis into the ipsilateralcapsule means; (e) placing the contralateral attachment system of thebifurcated prosthesis into the contralateral capsule means; (f) placingthe bifurcated prosthesis and the delivery means into the capsule jacketmeans; (g) creating an opening in the corporeal lumen for traversing thecapsule jacket means, the delivery means and the bifurcated prosthesistherethrough; (h) inserting the capsule jacket means, the delivery meansand the bifurcated prosthesis into the opening in the corporeal lumen;(i) urging the bifurcated prosthesis to a desired location within thecorporeal lumen; (j) positioning the distal capsule means at a desiredlocation within the corporeal lumen; (k) activating the superiorattachment system to secure the superior end of the bifurcatedprosthesis within the corporeal lumen; (l) positioning the contralateralcapsule means at a desired location within the corporeal lumen; (m)activating the contralateral attachment system to secure thecontralateral end of the bifurcated prosthesis within the corporeallumen; (n) positioning the ipsilateral capsule means at a desiredlocation within the corporeal lumen; (o) activating the ipsilateralattachment system to secure the ipsilateral end of the bifurcatedprosthesis within the corporeal lumen; (p) removing the delivery meansfrom the corporeal lumen; and (q) closing the opening in the corporeallumen.
 32. The method of claim 31, said method further comprising thesteps of: (r) withdrawing the capsule jacket means proximally to exposethe distal capsule means, bifurcated prosthesis, contralateral capsulemeans and at least a portion of the ipsilateral capsule means afterperforming step (i) and prior to performing step (j); (s) removing thesuperior attachment system from the distal capsule means afterperforming step (j) and prior to performing step (k); (t) removing thecontralateral attachment system from the contralateral capsule meansafter performing step (l) and prior to performing step (m); and (u)removing the ipsilateral attachment system from the ipsilateral capsulemeans after performing step (n) and prior to performing step (o).